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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT03198468




Registration number
NCT03198468
Ethics application status
Date submitted
14/06/2017
Date registered
26/06/2017
Date last updated
9/07/2020

Titles & IDs
Public title
Vapor Ablation for Localized Cancer Lesions of the Lung (VAPORIZE)
Scientific title
Vapor Ablation for Localized Cancer Lesions of the Lung - A Clinical Feasibility Treat-and Resect Study (VAPORIZE)
Secondary ID [1] 0 0
CSP-2313
Universal Trial Number (UTN)
Trial acronym
VAPORIZE
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Non Small Cell Lung Cancer 0 0
Metastatic Lung Cancer 0 0
Lung Cancer 0 0
Condition category
Condition code
Cancer 0 0 0 0
Lung - Mesothelioma
Cancer 0 0 0 0
Lung - Non small cell
Cancer 0 0 0 0
Lung - Small cell

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Devices - Bronchoscopic Thermal Vapor Ablation

Experimental: Vapor Ablation -


Treatment: Devices: Bronchoscopic Thermal Vapor Ablation
Vapor (steam) is infused into the targeted region for 8 seconds at a precisely controlled flow rate and power

Intervention code [1] 0 0
Treatment: Devices
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
BTVA-C related AEs/SAEs - The number of reported adverse events (AEs), serious adverse events (SAEs) related to the BTVA-C procedure.
Timepoint [1] 0 0
Day 30 follow-up
Primary outcome [2] 0 0
Successful BTVA-C Treatment Delivery - Treatment meets 100% of the required procedural steps/requirements per the Instructions For Use (IFU) and treatment is delivered to the target tumor per the individual patient navigational plan
Timepoint [2] 0 0
1 day post-ablation
Primary outcome [3] 0 0
Ischemic tissue assessment - CT Imaging to identify and assess ischemic tissue
Timepoint [3] 0 0
2-4 days post-ablation (pre surgical resection)
Primary outcome [4] 0 0
Tissue necrosis evaluated by semi-quantitative histological analysis - Semi-quantitative scoring of necrotic tissue assessed by histology
Timepoint [4] 0 0
1 day post-surgical resection

Eligibility
Key inclusion criteria
1. Age: = 18 years old

2. Non-small cell lung cancer tumor(s) = 2cm (T1aN0, T1bN0, T1aN1, or T1bN1) suitable for
resection OR Metastatic lung tumor(s) = 2cm suitable for resection

3. Suitable candidate for resection per standard of practice

4. Microscopic proof of malignancy obtained.

5. Location of tumor:

1. In periphery of lung (outermost 1/3)

2. Anticipation that resection would remove all gross tumor and ablation with
grossly negative margins

3. Maximum of three vapor ablation applications would target entire margin according
to the vapor ablation plan

6. Signed informed consent
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Centralized tumor not amenable to resection (abutting main stem bronchus, main
pulmonary artery branches, esophagus, or trachea)

2. Carcinoid lung tumors

3. Tumor is associated with atelectasis or obstructive pneumonitis or pleural effusion

4. Pulmonary function tests (PFTs): post-bronchodilator forced expired volume in one
second (FEV1) or forced vital capacity (FVC) < 50% predicted, diffusing capacity of
the lung for carbon monoxide (DLCO) <50% predicted

5. Requirement for supplemental oxygen at rest or exercise

6. Hospitalization for cardiac disease within the preceding 6 months

7. Liver enzymes (ALP, ALT, AST) or total bilirubin > 1.5 upper limit of normal (ULN)

8. Serum creatinine > 2 mg/dl

9. Recent infection (within 30 days)

10. Receiving immunosuppressive medication or prednisone > 10 mg/day (or equivalent)

11. Pregnant or breastfeeding women and those of childbearing potential who are not
practicing a reliable form of contraception.

12. Disorder of coagulation, history of severe hemoptysis, or receiving anticoagulant
medication. Antiplatelet medication is permitted provided that the medication can be
held a minimum of 7 days prior to the procedure and 10 days, post-procedure.

13. Any condition that in the opinion of the investigator or reviewer may interfere with
the safety of the patient or evaluation of the study objectives

14. Any tumor characteristic that in the opinion of the investigator or reviewers may
interfere with the safety of the patient or evaluation of the study objectives

Study design
Purpose of the study
Treatment
Allocation to intervention
N/A
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
The Royal Melbourne Hospital - Melbourne
Recruitment postcode(s) [1] 0 0
3050 - Melbourne

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Uptake Medical Technology, Inc.
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
This study is a prospective, single-arm, multi-center, pilot trial of Bronchoscopic Thermal
Vapor Ablation for Lung Cancer (BTVA-C) in patients with primary lung cancer or metastatic
cancer in the lung. Patients who have consented to participate in this study (enrolled) will
be subject to eligibility screening and baseline assessments, prior to undergoing the BTVA-C
procedure. Only patients that meet all of inclusion criteria and none of the exclusion
criteria will receive vapor ablation treatment.

Patients will receive BTVA-C treatment followed by standard-of-practice surgical resection.
Trial website
https://clinicaltrials.gov/show/NCT03198468
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Summary results
Other publications