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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT03820947
Registration number
NCT03820947
Ethics application status
Date submitted
8/01/2019
Date registered
29/01/2019
Date last updated
4/09/2025
Titles & IDs
Public title
VenaSeal Spectrum: Global Post-Market Randomized Controlled Trial
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Scientific title
Global, Post-Market, Prospective, Multi-Center, Randomized Controlled Trial of the VenaSeal™ Closure System vs. Surgical Stripping or Endothermal Ablation (ETA) for the Treatment of Early & Advanced Stage Superficial Venous Disease
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Secondary ID [1]
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MDT18034
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Venous Reflux
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Condition category
Condition code
Cardiovascular
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Diseases of the vasculature and circulation including the lymphatic system
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Skin
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Other skin conditions
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Devices - VenaSeal™ System
Treatment: Devices - Endothermal Ablation (ETA)
Treatment: Surgery - Surgical Stripping
Experimental: Randomized study VenaSeal™ System versus Endothermal Ablation (ETA): VenaSeal™ System - CEAP 2-5 subjects will be randomized to VenaSeal™ System vs. ETA
Active comparator: Randomized study VenaSeal™ System versus Endothermal Ablation (ETA): ETA - CEAP 2-5 subjects will be randomized to VenaSeal™ System vs. ETA
Experimental: Randomized study VenaSeal™ System versus Surgical Stripping: VenaSeal™ System - CEAP 2-5 subjects will be randomized to VenaSeal™ System vs. Surgical Stripping
Active comparator: Randomized study VenaSeal™ System versus Surgical Stripping: Surgical Stripping - CEAP 2-5 subjects will be randomized to VenaSeal™ System vs. Surgical Stripping
Experimental: Single arm Venous Leg Ulcer (VLU) Study: VenaSeal™ System - CEAP 6 active leg ulcer subjects will not be randomized to a comparator, all subjects will be treated with VenaSeal™ System
Treatment: Devices: VenaSeal™ System
The VenaSeal™ System is the non-tumescent, non-thermal, non-sclerosant device that uses a proprietary medical adhesive delivered endovenously to close the vein.
Treatment: Devices: Endothermal Ablation (ETA)
ETA includes EVLA that uses laser or RFA that uses radiofrequency heating to close the vein. Heat is applied in both EVLA and RFA therapies to close the vein.
Subject can be treated with either EVLA or RFA if randomized to ETA arm per site's standard practice.
Treatment: Surgery: Surgical Stripping
Surgical stripping involves stripping (removal) of the diseased vein via surgical procedures.
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Intervention code [1]
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Treatment: Devices
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Intervention code [2]
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Treatment: Surgery
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): Primary Endpoint: Peri-procedural Patient Satisfaction as Measured by a Validated, Patient-centered Venous Treatment Satisfaction Questionnaire (VenousTSQe) at 30 Days.
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Assessment method [1]
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Measured by a validated, patient-centered venous treatment satisfaction questionnaire - early (VenousTSQe). Total score ranges from 0-36, and a higher score means a higher peri-procedural venous treatment satisfaction.
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Timepoint [1]
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30 days
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Primary outcome [2]
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Randomized Study VenaSeal™ System Versus Surgical Stripping: Primary Endpoint: Peri-procedural Patient Satisfaction as Measured by a Validated, Patient-centered Venous Treatment Satisfaction Questionnaire (VenousTSQe) at 30 Days.
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Assessment method [2]
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Measured by a validated, patient-centered venous treatment satisfaction questionnaire - early (VenousTSQe). Total score ranges from 0-36, and a higher score means a higher peri-procedural venous treatment satisfaction.
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Timepoint [2]
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30 days
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Primary outcome [3]
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Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): Primary Endpoint: Patient Satisfaction as Measured by a Validated, Patient-centered Venous Treatment Satisfaction Questionnaire (VenousTSQs) at 30 Days.
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Assessment method [3]
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Measured by a validated, patient-centered venous treatment satisfaction questionnaire - status (VenousTSQs). Total score ranges from 0-36, and a higher score means a higher venous treatment satisfaction.
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Timepoint [3]
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30 days
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Primary outcome [4]
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Randomized Study VenaSeal™ System Versus Surgical Stripping: Primary Endpoint: Patient Satisfaction as Measured by a Validated, Patient-centered Venous Treatment Satisfaction Questionnaire (VenousTSQs) at 30 Days.
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Assessment method [4]
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0
Measured by a validated, patient-centered venous treatment satisfaction questionnaire - status (VenousTSQs). Total score ranges from 0-36, and a higher score means a higher venous treatment satisfaction.
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Timepoint [4]
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30 days
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Primary outcome [5]
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Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): Primary Endpoint: Elimination of Clinically Relevant Superficial Truncal Disease in Each Target Vein at the Time of Index Procedure.
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Assessment method [5]
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Elimination of clinically relevant superficial truncal disease in each target vein at the time of index procedure as measured by the percentage of target vein length successfully treated.
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Timepoint [5]
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Post Index procedure, on the day of the procedure immediately following treatment
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Primary outcome [6]
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Randomized Study VenaSeal™ System Versus Surgical Stripping: Primary Endpoint: Elimination of Clinically Relevant Superficial Truncal Disease in Each Target Vein at the Time of Index Procedure.
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Assessment method [6]
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Elimination of clinically relevant superficial truncal disease in each target vein at the time of index procedure as measured by the percentage of target vein length successfully treated.
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Timepoint [6]
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Post Index procedure, on the day of the procedure immediately following treatment
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Primary outcome [7]
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Single Arm Venous Leg Ulcer (VLU) Study: Primary Endpoint: Time to Ulcer Healing, Calculated Through Healing Confirmation and Verified by an Independent Core Laboratory Through 12 Months.
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Assessment method [7]
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Time to ulcer healing reported by using the cumulative incidence probability estimate of the event happening at 12 months, expressed as a percentage. The data values below represent the cumulative incidence probability as a percentage of participants with ulcer healing through 12 months.
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Timepoint [7]
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12 months
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Secondary outcome [1]
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Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): Key Secondary Endpoint: Anatomic Closure of the Primary Target Superficial Truncal Vein at 6 Months.
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Assessment method [1]
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Anatomic closure of the primary target superficial truncal vein, defined as DUS showing vein closure along the entire treated vein segment with no discrete segments of patency exceeding 5 cm after VenaSeal™ system and ETA procedures. Time to lack of anatomic closure was reported by using the Kaplan-Meier survival probability estimate at 6 months expressed as a percentage. The data values below represent the Kaplan-Meier survival probability as a percentage of primary target veins with anatomic closure through 6 months.
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Timepoint [1]
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6 months
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Secondary outcome [2]
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Randomized Study VenaSeal™ System Versus Surgical Stripping: Key Secondary Endpoint: Anatomic Closure of the Primary Target Superficial Truncal Vein at 6 Months.
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Assessment method [2]
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0
Anatomic closure of the primary target superficial truncal vein, defined as DUS showing vein closure along the entire treated vein segment with no discrete segments of patency exceeding 5 cm after VenaSeal™ system, or the absence of refluxing or residual primary target vein after surgical stripping procedures. Time to lack of anatomic closure was reported by using the Kaplan-Meier survival probability estimate at 6 months expressed as a percentage. The data values below represent the Kaplan-Meier survival probability as a percentage of primary target veins with anatomic closure through 6 months.
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Timepoint [2]
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0
6 months
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Secondary outcome [3]
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0
Single Arm Venous Leg Ulcer (VLU) Study: VenaSeal™ System: Key Secondary Endpoint: Anatomic Closure of the Primary Target Superficial Truncal Vein at 6 Months.
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Assessment method [3]
0
0
Anatomic closure of the primary target superficial truncal vein, defined as DUS showing vein closure along the entire treated vein segment with no discrete segments of patency exceeding 5 cm after VenaSeal™ system. Time to lack of anatomic closure was reported by using the Kaplan-Meier survival probability estimate at 6 months expressed as a percentage. The data values below represent the Kaplan-Meier survival probability as a percentage of primary target veins with anatomic closure through 6 months.
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Timepoint [3]
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0
6 months
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Secondary outcome [4]
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0
Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): Key Secondary Endpoint: Time to Return to Work as Reported by the Patient.
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Assessment method [4]
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Time to return to work reported by using the cumulative incidence probability estimate of the event happening at 30 days, expressed as a percentage. The data values below represent the cumulative incidence probability as the percentage of participants returning to work through 30 days.
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Timepoint [4]
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30 days
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Secondary outcome [5]
0
0
Randomized Study VenaSeal™ System Versus Surgical Stripping: Key Secondary Endpoint: Time to Return to Work as Reported by the Patient.
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Assessment method [5]
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0
Time to return to work reported by using the cumulative incidence probability estimate of the event happening at 30 days, expressed as a percentage. The data values below represent the cumulative incidence probability as the percentage of participants returning to work through 30 days.
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Timepoint [5]
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0
30 days
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Secondary outcome [6]
0
0
Single Arm Venous Leg Ulcer (VLU) Study: VenaSeal™ System: Key Secondary Endpoint: Time to Return to Work as Reported by the Patient.
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Assessment method [6]
0
0
Time to return to work reported by using the cumulative incidence probability estimate of the event happening at 30 days, expressed as a percentage. The data values below represent the cumulative incidence probability as the percentage of participants returning to work through 30 days.
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Timepoint [6]
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0
30 days
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Secondary outcome [7]
0
0
Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): Secondary Endpoint: Anatomic Closure of Primary Target Vein at 30 Days, and 12, 24, 36, 48 and 60 Months.
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Assessment method [7]
0
0
For subjects treated with the VenaSeal™ system or ETA it is defined as DUS showing vein closure along the entire treated vein segment with no discrete segments of patency exceeding 5 cm. Time to lack of anatomic closure was reported by using the Kaplan-Meier survival probability estimate at 30 days and 12 months, expressed as a percentage. The data values below represent the Kaplan-Meier survival probability as a percentage of primary target veins with anatomic closure through 30 days and 12 months.
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Timepoint [7]
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0
30 days and 12 months. Data for additional time points 24, 36, 48 and 60 months will be added to additional outcome measure with next posting as data collection is still ongoing.
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Secondary outcome [8]
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0
Randomized Study VenaSeal™ System Versus Surgical Stripping: Secondary Endpoint: Anatomic Closure of Primary Target Vein at 30 Days, and 12 Months.
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Assessment method [8]
0
0
Anatomic closure of the primary target superficial truncal vein, defined as DUS showing vein closure along the entire treated vein segment with no discrete segments of patency exceeding 5 cm after VenaSeal™ system, or the absence of refluxing or residual primary target vein after surgical stripping procedures. Time to lack of anatomic closure was reported by using the Kaplan-Meier survival probability estimate at 30 days and 12 months, expressed as a percentage. The data values below represent the Kaplan-Meier survival probability as a percentage of primary target veins with anatomic closure through 30 days and 12 months.
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Timepoint [8]
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0
30 days, 12 months
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Secondary outcome [9]
0
0
Single Arm Venous Leg Ulcer (VLU) Study: VenaSeal™ System: Secondary Endpoint: Anatomic Closure of Primary Target Vein at 30 Days, and 12, 24, 36, 48 and 60 Months.
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Assessment method [9]
0
0
For subjects treated with the VenaSeal™ system it is defined as DUS showing vein closure along the entire treated vein segment with no discrete segments of patency exceeding 5 cm. Time to lack of anatomic closure was reported by using the Kaplan-Meier survival probability estimate at 30 days and 12 months, expressed as a percentage. The data values below represent the Kaplan-Meier survival probability as a percentage of primary target veins with anatomic closure through 30 days and 12 months.
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Timepoint [9]
0
0
30 days and 12 months. Data for additional time points 24, 36, 48 and 60 months will be added to additional outcome measure with next posting as data collection is still ongoing.
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Secondary outcome [10]
0
0
Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): Secondary Endpoint: Anatomic Closure of Target Vein at 30 Days, and 6, 12, 24, 36, 48 and 60 Months.
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Assessment method [10]
0
0
For subjects treated with the VenaSeal™ system or ETA this is defined as DUS showing vein closure along the entire treated vein segment with no discrete segments of patency exceeding 5 cm. Time to lack of anatomic closure was reported by using the Kaplan-Meier survival probability estimate at 30 days, 6 months, and 12 months, expressed as a percentage. The data values below represent the Kaplan-Meier survival probability as a percentage of target veins with anatomic closure through 30 days, 6 months, and 12 months.
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Timepoint [10]
0
0
30 days, and 6, 12 months. Data for additional time points 24, 36, 48 and 60 months will be added to additional outcome measure with next posting as data collection is still ongoing.
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Secondary outcome [11]
0
0
Randomized Study VenaSeal™ System Versus Surgical Stripping: Secondary Endpoint: Anatomic Closure of Target Vein at 30 Days, and 6, 12 Months.
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Assessment method [11]
0
0
Anatomic closure of target superficial truncal vein defined as DUS showing vein closure along the entire treated vein segment with no discrete segments of patency exceeding 5 cm after VenaSeal™ system, or the absence of refluxing or residual primary target vein after surgical stripping procedures. Time to lack of anatomic closure was reported by using the Kaplan-Meier survival probability estimate at 30 days, 6 months, and 12 months, expressed as a percentage. The data values below represent the Kaplan-Meier survival probability as a percentage of target veins with anatomic closure through 30 days, 6 months, and 12 months.
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Timepoint [11]
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0
30 days, 6, 12 months
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Secondary outcome [12]
0
0
Single Arm Venous Leg Ulcer (VLU) Study: VenaSeal™ System: Secondary Endpoint: Anatomic Closure of Target Vein at 30 Days, and 6, 12, 24, 36, 48 and 60 Months.
Query!
Assessment method [12]
0
0
For subjects treated with the VenaSeal™ system this is defined as DUS showing vein closure along the entire treated vein segment with no discrete segments of patency exceeding 5 cm. Time to lack of anatomic closure was reported by using the Kaplan-Meier survival probability estimate at 30 days, 6 months, and 12 months, expressed as a percentage. The data values below represent the Kaplan-Meier survival probability as a percentage of target veins with anatomic closure through 30 days, 6 months, and 12 months.
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Timepoint [12]
0
0
30 days, and 6, 12 months. Data for additional time points 24, 36, 48 and 60 months will be added to additional outcome measure with next posting as data collection is still ongoing.
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Secondary outcome [13]
0
0
Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): Secondary Endpoint: Technical Success of Each Target Vein Immediately Post-index Procedure.
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Assessment method [13]
0
0
For subjects treated with the VenaSeal™ system or ETA this is defined as DUS showing vein closure along the entire treated vein segment with no discrete segments of patency exceeding 5 cm.
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Timepoint [13]
0
0
Post Index procedure, on the day of the procedure immediately following treatment
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Secondary outcome [14]
0
0
Randomized Study VenaSeal™ System Versus Surgical Stripping: Secondary Endpoint: Technical Success of Each Target Vein Immediately Post-index Procedure.
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Assessment method [14]
0
0
Defined as DUS showing vein closure along the entire treated vein segment with no discrete segments of patency exceeding 5 cm after VenaSeal™ system, or the absence of refluxing or residual vein after surgical stripping procedures.
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Timepoint [14]
0
0
Post Index procedure, on the day of the procedure immediately following treatment
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Secondary outcome [15]
0
0
Single Arm Venous Leg Ulcer (VLU) Study: VenaSeal™ System: Secondary Endpoint: Technical Success of Each Target Vein Immediately Post-index Procedure.
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Assessment method [15]
0
0
For subjects treated with the VenaSeal™ system this is defined as DUS showing vein closure along the entire treated vein segment with no discrete segments of patency exceeding 5 cm.
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Timepoint [15]
0
0
Post Index procedure, on the day of the procedure immediately following treatment
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Secondary outcome [16]
0
0
Randomized Study VenaSeal™ System Versus Surgical Stripping: Secondary Endpoint: Reintervention of Any Target Vein (Including Primary Target Vein) Through 12 Months, Assessed at Each Follow-up Visit.
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Assessment method [16]
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0
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Timepoint [16]
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0
12 months
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Secondary outcome [17]
0
0
Randomized Study VenaSeal™ System Versus Surgical Stripping: Secondary Endpoint: Time to Reintervention of Any Target Vein (Including Primary Target Vein) Through 12 Months.
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Assessment method [17]
0
0
As measured by the time between the index procedure and the first reintervention procedure. Time to reintervention was reported by using the event free Kaplan-Meier survival probability estimate at 12 months expressed as a percentage. The data values below represent the Kaplan-Meier survival probability as a percentage of target veins without a reintervention through 12 months.
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Timepoint [17]
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0
12 months
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Secondary outcome [18]
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0
Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): Secondary Endpoint: Adverse Events (AEs) Occurring in the Target Limb, Evaluated From Index Procedure Through 12 Months.
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Assessment method [18]
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0
Hypersensitivity to VenaSeal™ adhesive, Phlebitis, Granuloma, Endovenous glue induced thrombosis (EGIT) or endovenous heat induced thrombosis (EHIT), Symptomatic deep vein thrombosis (DVT) events.
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Timepoint [18]
0
0
12 months
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Secondary outcome [19]
0
0
Randomized Study VenaSeal™ System Versus Surgical Stripping: Secondary Endpoint: Adverse Events (AEs) Occurring in the Target Limb, Evaluated From Index Procedure Through 12 Months.
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Assessment method [19]
0
0
Hypersensitivity to VenaSeal™ adhesive, Phlebitis, Granuloma, Endovenous glue induced thrombosis (EGIT), Symptomatic deep vein thrombosis (DVT) events.
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Timepoint [19]
0
0
12 months
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Secondary outcome [20]
0
0
Single Arm Venous Leg Ulcer (VLU) Study: VenaSeal™ System: Secondary Endpoint: Adverse Events (AEs) Occurring in the Target Limb, Evaluated From Index Procedure Through 12 Months.
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Assessment method [20]
0
0
Hypersensitivity to VenaSeal™ adhesive, Phlebitis, Granuloma, Endovenous glue induced thrombosis (EGIT), Symptomatic deep vein thrombosis (DVT) events.
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Timepoint [20]
0
0
12 months
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Secondary outcome [21]
0
0
Randomized Study VenaSeal™ System Versus Surgical Stripping: Secondary Endpoint: Additional Events Evaluated Through 12 Months.
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Assessment method [21]
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0
Symptomatic pulmonary embolism (PE), Serious adverse events (SAEs).
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Timepoint [21]
0
0
12 months
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Secondary outcome [22]
0
0
Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): Secondary Endpoint: Number and Type of Adjunctive Treatments Conducted Through 12 Months Post-index Procedure.
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Assessment method [22]
0
0
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Timepoint [22]
0
0
12 months
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Secondary outcome [23]
0
0
Randomized Study VenaSeal™ System Versus Surgical Stripping: Secondary Endpoint: Number and Type of Adjunctive Treatments Conducted Through 12 Months Post-index Procedure.
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Assessment method [23]
0
0
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Timepoint [23]
0
0
12 months
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Secondary outcome [24]
0
0
Single Arm Venous Leg Ulcer (VLU) Study: Secondary Endpoint: Number and Type of Adjunctive Treatments Conducted Through 12 Months Post-index Procedure.
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Assessment method [24]
0
0
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Timepoint [24]
0
0
12 months
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Secondary outcome [25]
0
0
Randomized Study VenaSeal™ System Versus Surgical Stripping: Secondary Endpoint: Healthcare Utilization Related to the Target Limb VRD.
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Assessment method [25]
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0
Determined by the number of healthcare visits conducted, and other health-related resources utilized (e.g., home healthcare services) between study visits through 12 months.
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Timepoint [25]
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0
12 months
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Secondary outcome [26]
0
0
Randomized Study VenaSeal™ System Versus Surgical Stripping: Secondary Endpoint: Procedures, Tests and Treatment of AEs Related to the Treatment Modality or Index Procedure Through 12 Months.
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Assessment method [26]
0
0
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Timepoint [26]
0
0
12 months
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Secondary outcome [27]
0
0
Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): Secondary Endpoint: Time to Return to Normal Activities as Reported by the Patients.
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Assessment method [27]
0
0
Time to return to normal activities reported by using the cumulative incidence probability estimate of the event happening at 30 days, expressed as a percentage. The data values below represent the cumulative incidence probability as the percentage of participants returning to normal activities through 30 days.
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Timepoint [27]
0
0
30 days
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Secondary outcome [28]
0
0
Randomized Study VenaSeal™ System Versus Surgical Stripping: Secondary Endpoint: Time to Return to Normal Activities as Reported by the Patients.
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Assessment method [28]
0
0
Time to return to normal activities reported by using the cumulative incidence probability estimate of the event happening at 30 days, expressed as a percentage. The data values below represent the cumulative incidence probability as the percentage of participants returning to normal activities through 30 days.
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Timepoint [28]
0
0
30 days
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Secondary outcome [29]
0
0
Single Arm Venous Leg Ulcer (VLU) Study: Secondary Endpoint: Time to Return to Normal Activities as Reported by the Patients.
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Assessment method [29]
0
0
Time to return to normal activities reported by using the cumulative incidence probability estimate of the event happening at 30 days, expressed as a percentage. The data values below represent the cumulative incidence probability as the percentage of participants returning to normal activities through 30 days.
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Timepoint [29]
0
0
30 days
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Secondary outcome [30]
0
0
Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): Secondary Endpoint: Intra-procedural and Post-procedural Pain at the Index Procedure, and 7 Days and 30 Days.
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Assessment method [30]
0
0
Determined by using numeric rating scale (NRS) with a scale of 0-10, with '0' indicating no pain and '10' indicating worst pain imaginable.
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Timepoint [30]
0
0
Intra-procedure, post-procedure (on the day of the procedure immediately following treatment), 7 days and 30 days
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Secondary outcome [31]
0
0
Randomized Study VenaSeal™ System Versus Surgical Stripping: Secondary Endpoint: Intra-procedural and Post-procedural Pain at the Index Procedure, and 7 Days and 30 Days.
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Assessment method [31]
0
0
Determined by using numeric rating scale (NRS) with a scale of 0-10, with '0' indicating no pain and '10' indicating worst pain imaginable.
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Timepoint [31]
0
0
Intra-procedure, post-procedure (on the day of the procedure immediately following treatment), 7 days and 30 days
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Secondary outcome [32]
0
0
Single Arm Venous Leg Ulcer (VLU) Study: Secondary Endpoint: Intra-procedural and Post-procedural Pain at the Index Procedure, and 7 Days and 30 Days.
Query!
Assessment method [32]
0
0
Determined by using numeric rating scale (NRS) with a scale of 0-10, with '0' indicating no pain and '10' indicating worst pain imaginable.
Query!
Timepoint [32]
0
0
Intra-procedure, post-procedure (on the day of the procedure immediately following treatment), 7 days and 30 days
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Secondary outcome [33]
0
0
Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): Secondary Endpoint: Change in Venous Disease Symptoms at 7 and 30 Days, and at 6, 12, 24, 36, 48, and 60 Months Compared to Baseline.
Query!
Assessment method [33]
0
0
Measured by the revised Venous Clinical Severity Score (rVCSS) and subject self-reporting. rVCSS score ranges from 0 to 30, with higher score indicating severe venous disease. The outcome measure data reports changes compared to baseline at the different time frames.
Query!
Timepoint [33]
0
0
7 and 30 days, and at 6, 12 months. Data for additional time points 24, 36, 48 and 60 months will be added to additional outcome measure with next posting as data collection is still ongoing.
Query!
Secondary outcome [34]
0
0
Randomized Study VenaSeal™ System Versus Surgical Stripping: Secondary Endpoint: Change in Venous Disease Symptoms at 7 and 30 Days, and at 6, 12 Months Compared to Baseline.
Query!
Assessment method [34]
0
0
Measured by the revised Venous Clinical Severity Score (rVCSS) and subject self-reporting. rVCSS score ranges from 0 to 30, with higher score indicating severe venous disease. The outcome measure data reports changes compared to baseline at the different time frames.
Query!
Timepoint [34]
0
0
7 and 30 days, and at 6 and 12 months
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Secondary outcome [35]
0
0
Single Arm Venous Leg Ulcer (VLU) Study: Secondary Endpoint: Change in Venous Disease Symptoms at 7 and 30 Days, and at 6, 12, 24, 36, 48, and 60 Months Compared to Baseline.
Query!
Assessment method [35]
0
0
Measured by the revised Venous Clinical Severity Score (rVCSS) and subject self-reporting. rVCSS score ranges from 0 to 30, with higher score indicating severe venous disease. The outcome measure data reports changes compared to baseline at the different time frames.
Query!
Timepoint [35]
0
0
7 and 30 days, and at 6, 12 months. Data for additional time points 24, 36, 48 and 60 months will be added to additional outcome measure with next posting as data collection is still ongoing.
Query!
Secondary outcome [36]
0
0
Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): Secondary Endpoint: Change in AVVQ Score at 30 Days, and 6, 12, 24, 36, 48, and 60 Months Compared to Baseline.
Query!
Assessment method [36]
0
0
The total score ranges from 0-100 points, with '0' point indicating the best quality of life and '100' points indicating worst quality of life. The outcome measure data reports changes compared to baseline at the different time frames.
Query!
Timepoint [36]
0
0
30 days, and 6, 12 months. Data for additional time points 24, 36, 48 and 60 months will be added to additional outcome measure with next posting as data collection is still ongoing.
Query!
Secondary outcome [37]
0
0
Randomized Study VenaSeal™ System Versus Surgical Stripping: Secondary Endpoint: Change in AVVQ Score at 30 Days, and 6 and 12 Months Compared to Baseline.
Query!
Assessment method [37]
0
0
The total score ranges from 0-100 points, with '0' point indicating the best quality of life and '100' points indicating worst quality of life. The outcome measure data reports changes compared to baseline at the different time frames.
Query!
Timepoint [37]
0
0
30 days, and 6 and 12 months
Query!
Secondary outcome [38]
0
0
Single Arm Venous Leg Ulcer (VLU) Study: Secondary Endpoint: Change in AVVQ Score at 30 Days, and 6, 12, 24, 36, 48, and 60 Months Compared to Baseline.
Query!
Assessment method [38]
0
0
The total score ranges from 0-100 points, with '0' point indicating the best quality of life and '100' points indicating worst quality of life. The outcome measure data reports changes compared to baseline at the different time frames.
Query!
Timepoint [38]
0
0
30 days, and 6, 12 months. Data for additional time points 24, 36, 48 and 60 months will be added to additional outcome measure with next posting as data collection is still ongoing.
Query!
Secondary outcome [39]
0
0
Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): Secondary Endpoint: Change in EuroQoL Group 5-Dimension Self-Report Questionnaire (EQ-5D-5L) at 30 Days, and 6, 12, 24, 36, 48 and 60 Months Compared to Baseline.
Query!
Assessment method [39]
0
0
EQ-5D Index scale from \<0 to 1.0 (\<0 worse than dead, 0 is dead and 1.0 is full health). The outcome measure data reports changes compared to baseline at the different time frames.
Query!
Timepoint [39]
0
0
30 days, and 6, 12 months. Data for additional time points 24, 36, 48 and 60 months will be added to additional outcome measure with next posting as data collection is still ongoing.
Query!
Secondary outcome [40]
0
0
Randomized Study VenaSeal™ System Versus Surgical Stripping: Secondary Endpoint: Change in EuroQoL Group 5-Dimension Self-Report Questionnaire (EQ-5D-5L) at 30 Days, and 6 and 12 Months Compared to Baseline.
Query!
Assessment method [40]
0
0
EQ-5D Index scale from \<0 to 1.0 (\<0 worse than dead, 0 is dead and 1.0 is full health). The outcome measure data reports changes compared to baseline at the different time frames.
Query!
Timepoint [40]
0
0
30 days, and 6 and 12 months
Query!
Secondary outcome [41]
0
0
Single Arm Venous Leg Ulcer (VLU) Study: Secondary Endpoint: Change in EuroQoL Group 5-Dimension Self-Report Questionnaire (EQ-5D-5L) at 30 Days, and 6, 12, 24, 36, 48 and 60 Months Compared to Baseline.
Query!
Assessment method [41]
0
0
EQ-5D Index scale from \<0 to 1.0 (\<0 worse than dead, 0 is dead and 1.0 is full health). The outcome measure data reports changes compared to baseline at the different time frames.
Query!
Timepoint [41]
0
0
30 days, and 6, 12 months. Data for additional time points 24, 36, 48 and 60 months will be added to additional outcome measure with next posting as data collection is still ongoing.
Query!
Secondary outcome [42]
0
0
Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): Secondary Endpoint: Change in the 36-Item Short Form Health Survey (SF-36) Reported by the Patient at 30 Days, and 6 and 12 Months Compared to Baseline.
Query!
Assessment method [42]
0
0
The total score ranges from 0 to 100, with higher scores indicating better general health perception. The outcome measure data reports changes compared to baseline at the different time frames.
Query!
Timepoint [42]
0
0
30 days, and 6 and 12 months
Query!
Secondary outcome [43]
0
0
Randomized Study VenaSeal™ System Versus Surgical Stripping: Secondary Endpoint: Change in the 36-Item Short Form Health Survey (SF-36) Reported by the Patient at 30 Days, and 6 and 12 Months Compared to Baseline.
Query!
Assessment method [43]
0
0
The total score ranges from 0 to 100, with higher scores indicating better general health perception. The outcome measure data reports changes compared to baseline at the different time frames.
Query!
Timepoint [43]
0
0
30 days, and 6 and 12 months
Query!
Secondary outcome [44]
0
0
Single Arm Venous Leg Ulcer (VLU) Study: Secondary Endpoint: Change in the 36-Item Short Form Health Survey (SF-36) Reported by the Patient at 30 Days, and 6 and 12 Months Compared to Baseline.
Query!
Assessment method [44]
0
0
The total score ranges from 0 to 100, with higher scores indicating better general health perception. The outcome measure data reports changes compared to baseline at the different time frames.
Query!
Timepoint [44]
0
0
30 days, and 6 and 12 months
Query!
Secondary outcome [45]
0
0
Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): Secondary Endpoint: Change in the Venous Dependent Quality of Life (VenousDQoL) Reported by the Patient at 30 Days, and 6, 12, 24, 36, 48, and 60 Months Compared to Baseline.
Query!
Assessment method [45]
0
0
Subjects answer their general quality of life with potential responses on an ordinal scale: excellent, very good, good, neither good nor bad, bad, very bad, or extremely bad. Subjects also answer what their quality of life would be without varicose veins with potential responses on an ordinal scale: very much better, much better, a little better, the same, or worse. The outcome measure data reports the responses at the different time frames including baseline.
Query!
Timepoint [45]
0
0
30 days, and 6, 12 months. Data for additional time points 24, 36, 48 and 60 months will be added to additional outcome measure with next posting as data collection is still ongoing.
Query!
Secondary outcome [46]
0
0
Randomized Study VenaSeal™ System Versus Surgical Stripping: Secondary Endpoint: Change in the Venous Dependent Quality of Life (VenousDQoL) Reported by the Patient at 30 Days, and 6, 12 Months Compared to Baseline.
Query!
Assessment method [46]
0
0
Subjects answer their general quality of life with potential responses on an ordinal scale: excellent, very good, good, neither good nor bad, bad, very bad, or extremely bad. Subjects also answer what their quality of life would be without varicose veins with potential responses on an ordinal scale: very much better, much better, a little better, the same, or worse. The outcome measure data reports the responses at the different time frames including baseline.
Query!
Timepoint [46]
0
0
30 days, and 6, 12 months
Query!
Secondary outcome [47]
0
0
Single Arm Venous Leg Ulcer (VLU) Study: Secondary Endpoint: Change in the Venous Dependent Quality of Life (VenousDQoL) Reported by the Patient at 30 Days, and 6, 12, 24, 36, 48, and 60 Months Compared to Baseline.
Query!
Assessment method [47]
0
0
Subjects answer their general quality of life with potential responses on an ordinal scale: excellent, very good, good, neither good nor bad, bad, very bad, or extremely bad. Subjects also answer what their quality of life would be without varicose veins with potential responses on an ordinal scale: very much better, much better, a little better, the same, or worse. The outcome measure data reports the responses at the different time frames including baseline.
Query!
Timepoint [47]
0
0
30 days, and 6, 12 months. Data for additional time points 24, 36, 48 and 60 months will be added to additional outcome measure with next posting as data collection is still ongoing.
Query!
Secondary outcome [48]
0
0
Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): Secondary Endpoint: Provider Experience Will be Assessed Post-index Procedure, Evaluating Overall Satisfaction With the Procedure.
Query!
Assessment method [48]
0
0
Measured by a 5 point Likert scale ranging from 0-5, with 5 indicating the best outcome (extremely satisfied with the treatment).
Query!
Timepoint [48]
0
0
Post-index procedure, on the day of the procedure immediately following treatment
Query!
Secondary outcome [49]
0
0
Randomized Study VenaSeal™ System Versus Surgical Stripping: Secondary Endpoint: Provider Experience Will be Assessed Post-index Procedure, Evaluating Overall Satisfaction With the Procedure.
Query!
Assessment method [49]
0
0
Measured by a 5 point Likert scale ranging from 0-5, with 5 indicating the best outcome (extremely satisfied with the treatment).
Query!
Timepoint [49]
0
0
Post-index procedure, on the day of the procedure immediately following treatment
Query!
Secondary outcome [50]
0
0
Single Arm Venous Leg Ulcer (VLU) Study: Secondary Endpoint: Provider Experience Will be Assessed Post-index Procedure, Evaluating Overall Satisfaction With the Procedure.
Query!
Assessment method [50]
0
0
Measured by a 5 point Likert scale ranging from 0-5, with 5 indicating the best outcome (extremely satisfied with the treatment).
Query!
Timepoint [50]
0
0
Post-index procedure, on the day of the procedure immediately following treatment
Query!
Secondary outcome [51]
0
0
Single Arm Venous Leg Ulcer (VLU) Study: Secondary Endpoint: Peri-procedural Patient Satisfaction as Measured by a Validated Patient-centered Venous Treatment Satisfaction Questionnaire (VenousTSQe) at 30 Days.
Query!
Assessment method [51]
0
0
Measured by a validated, patient-centered venous treatment satisfaction questionnaire - early (VenousTSQe). Total score ranges from 0-36, and a higher score means a higher peri-procedural venous treatment satisfaction.
Query!
Timepoint [51]
0
0
30 days
Query!
Secondary outcome [52]
0
0
Single Arm Venous Leg Ulcer (VLU) Study: Secondary Endpoint: Patient Satisfaction as Measured by a Validated Patient-centered Venous Treatment Satisfaction Questionnaire (VenousTSQs) at 30 Days.
Query!
Assessment method [52]
0
0
Measured by a validated, patient-centered venous treatment satisfaction questionnaire - status (VenousTSQs). Total score ranges from 0-36, and a higher score means a higher venous treatment satisfaction.
Query!
Timepoint [52]
0
0
30 days
Query!
Secondary outcome [53]
0
0
Single Arm Venous Leg Ulcer (VLU) Study: Secondary Endpoint: Elimination of Clinically Relevant Superficial Truncal Disease in Target Vein at the Time of Index Procedure as Measured by the Percentage of Target Veins Successfully Treated.
Query!
Assessment method [53]
0
0
Elimination of clinically relevant superficial truncal disease in each target vein at the time of index procedure as measured by the percentage of target vein length successfully treated.
Query!
Timepoint [53]
0
0
Post-index procedure, on the day of the procedure immediately following treatment
Query!
Eligibility
Key inclusion criteria
1. Patient is =18 years of age
2. Patient has venous reflux in superficial truncal vein(s) (e.g., GSV, SSV, accessory saphenous veins) with CEAP 2 (symptomatic) or CEAP 3, 4a, 4b, 5, 6, appropriate for treatment, as confirmed by Duplex Ultrasound (DUS)
3. Eligibility for treatment:
* VenaSeal vs ETA Study: Patient is eligible for treatment with the VenaSeal™ system and ETA
* VenaSeal vs Surgical Stripping Study: Patient is eligible for treatment with the VenaSeal™ system and surgical stripping
* VLU Study: patients should be eligible for treatment with the VenaSeal™ system
4. Treatable refluxing segment of target vein(s) 10 cm in length or longer
5. Patient has a target vein diameter of =3 mm throughout the intended treated segment of the target vein as measured by DUS while patient is standing
6. Patient is willing and capable of complying with specified follow-up evaluations at the specified times
7. Patient has an ability to understand the requirements of the study and to provide informed consent
Query!
Minimum age
18
Years
Query!
Query!
Maximum age
No limit
Query!
Query!
Sex
Both males and females
Query!
Can healthy volunteers participate?
No
Query!
Key exclusion criteria
1. Patient has a known history of allergic sensitivities (including but not limited to cyanoacrylate adhesives), or any other condition, which in the opinion of the investigator may make the patient more susceptible to cyanoacrylate adhesive hypersensitivity
2. Patient has known deep vein obstruction in the target limb, as identified by the site's standard of care
3. Patient has abnormal pulse exam or ABI <0.8
4. Patient has acute superficial thrombophlebitis
5. Patient requires any non-target vein treatments in the contralateral or ipsilateral limb, or any other surgical procedure up tp 30 days pre-procedure and through 3 months post-procedure
6. Patient has any co-morbid conditions, which in the investigator's opinion may interfere with the patient's compliance with study visits and procedures, or may confound interpretation of study data (e.g., congestive heart failure Class III and IV, non-ambulatory patients, severe hepatic dysfunction, life expectancy < 1 year)
7. IFU contraindications:
* VenaSeal vs. ETA Study: Patient has VenaSeal™ system and/or ETA product's IFU contraindication(s)
* VenaSeal vs Surgical Stripping Study: Patient has surgical stripping and/or VenaSeal™ system IFU contraindication(s)
* VLU Study: Patient has VenaSeal™ system IFU contraindication(s)
8. Patient is non-ambulatory
9. Patient is a female of childbearing potential who may be pregnant or breastfeeding at the time of the index procedure
10. Patient belongs to a vulnerable population per investigator's judgment or patient has any kind of disorder that compromises his/her ability to give written informed consent and/or to comply with study procedures
11. Patient is currently participating in an investigational drug or device study when the data collected could be conflicting or biased due to participation in another study
12. Patient has documented COVID-19 infection currently or within the past 3 months. Patient is not completely recovered from past COVID-19 infection, per physician's discretion.
13. VLU Study: Patient has target ulceration identified to be of non-venous etiology, as confirmed by the independent core laboratory
14. VLU Study: Patient has target circumferential ulceration that cannot be captured in a single photograph (any ulcer curvature around the leg that goes out of sight)
Query!
Study design
Purpose of the study
Treatment
Query!
Allocation to intervention
Randomised controlled trial
Query!
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Query!
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Query!
Masking / blinding
Open (masking not used)
Query!
Who is / are masked / blinded?
Query!
Query!
Query!
Query!
Intervention assignment
Parallel
Query!
Other design features
Query!
Phase
Not applicable
Query!
Type of endpoint/s
Query!
Statistical methods / analysis
Query!
Recruitment
Recruitment status
Active, not recruiting
Query!
Data analysis
Query!
Reason for early stopping/withdrawal
Query!
Other reasons
Query!
Date of first participant enrolment
Anticipated
Query!
Actual
5/02/2020
Query!
Date of last participant enrolment
Anticipated
Query!
Actual
Query!
Date of last data collection
Anticipated
30/04/2028
Query!
Actual
Query!
Sample size
Target
Query!
Accrual to date
Query!
Final
506
Query!
Recruitment in Australia
Recruitment state(s)
Query!
Recruitment hospital [1]
0
0
Sunshine Coast University Hospital - Birtinya
Query!
Recruitment hospital [2]
0
0
Wollongong Hospital - Wollongong
Query!
Recruitment postcode(s) [1]
0
0
4575 - Birtinya
Query!
Recruitment postcode(s) [2]
0
0
- Wollongong
Query!
Recruitment outside Australia
Country [1]
0
0
United States of America
Query!
State/province [1]
0
0
Arizona
Query!
Country [2]
0
0
United States of America
Query!
State/province [2]
0
0
California
Query!
Country [3]
0
0
United States of America
Query!
State/province [3]
0
0
Connecticut
Query!
Country [4]
0
0
United States of America
Query!
State/province [4]
0
0
District of Columbia
Query!
Country [5]
0
0
United States of America
Query!
State/province [5]
0
0
Massachusetts
Query!
Country [6]
0
0
United States of America
Query!
State/province [6]
0
0
New York
Query!
Country [7]
0
0
United States of America
Query!
State/province [7]
0
0
Ohio
Query!
Country [8]
0
0
United States of America
Query!
State/province [8]
0
0
Texas
Query!
Country [9]
0
0
United States of America
Query!
State/province [9]
0
0
Washington
Query!
Country [10]
0
0
Canada
Query!
State/province [10]
0
0
Ontario
Query!
Country [11]
0
0
France
Query!
State/province [11]
0
0
DIjon Cedex
Query!
Country [12]
0
0
France
Query!
State/province [12]
0
0
Lyon
Query!
Country [13]
0
0
France
Query!
State/province [13]
0
0
Toulouse
Query!
Country [14]
0
0
Germany
Query!
State/province [14]
0
0
Halle
Query!
Country [15]
0
0
Italy
Query!
State/province [15]
0
0
Milan
Query!
Country [16]
0
0
Italy
Query!
State/province [16]
0
0
Padua
Query!
Country [17]
0
0
Netherlands
Query!
State/province [17]
0
0
Arnhem
Query!
Country [18]
0
0
South Korea
Query!
State/province [18]
0
0
Seoul
Query!
Country [19]
0
0
Spain
Query!
State/province [19]
0
0
Granada
Query!
Country [20]
0
0
Spain
Query!
State/province [20]
0
0
Madrid
Query!
Country [21]
0
0
United Kingdom
Query!
State/province [21]
0
0
Bedford
Query!
Country [22]
0
0
United Kingdom
Query!
State/province [22]
0
0
Cambridge
Query!
Country [23]
0
0
United Kingdom
Query!
State/province [23]
0
0
Harrow
Query!
Country [24]
0
0
United Kingdom
Query!
State/province [24]
0
0
London
Query!
Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Query!
Name
Medtronic Endovascular
Query!
Address
Query!
Country
Query!
Ethics approval
Ethics application status
Query!
Summary
Brief summary
Global, Post-Market, Prospective, Multi-Center, Randomized Controlled Trial of the VenaSeal™ Closure System vs. Surgical Stripping or Endothermal Ablation (ETA) for the Treatment of Early and Advanced Stage Superficial Venous Disease
Query!
Trial website
https://clinicaltrials.gov/study/NCT03820947
Query!
Trial related presentations / publications
Query!
Public notes
Query!
Contacts
Principal investigator
Name
0
0
Kathleen Gibson, MD
Query!
Address
0
0
Lake Washington Vascular, US
Query!
Country
0
0
Query!
Phone
0
0
Query!
Fax
0
0
Query!
Email
0
0
Query!
Contact person for public queries
Name
0
0
Query!
Address
0
0
Query!
Country
0
0
Query!
Phone
0
0
Query!
Fax
0
0
Query!
Email
0
0
Query!
Contact person for scientific queries
Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
Query!
No/undecided IPD sharing reason/comment
Query!
What supporting documents are/will be available?
No Supporting Document Provided
Type
Other Details
Attachment
Study protocol
https://cdn.clinicaltrials.gov/large-docs/47/NCT03820947/Prot_000.pdf
Statistical analysis plan
https://cdn.clinicaltrials.gov/large-docs/47/NCT03820947/SAP_001.pdf
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results are available at
https://clinicaltrials.gov/study/NCT03820947
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