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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT07916857




Registration number
Help: Registration number
NCT07916857
Ethics application status
Help: Ethics application status
Date submitted
Help: Date submitted
29/10/2026
Date registered
Help: Date registered
4/11/2026
Date last updated
Help: Date last updated
4/11/2026

Titles & IDs
Public title
Comparison of VxWave and Standard Ultrasound Measurements of Blood Vessels in the Arm
Scientific title
The VxWave Ultrasound Imaging System Upper Limb Clinical Performance Trial
Additional trial identifiers [1] 0 0
CIP-2
Universal Trial Number (UTN)
Trial acronym
Related trial records

Health condition
Health condition(s) studied:
Upper Limb Vascular Imaging 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of the intervention or exposure
Treatment: Devices - VxWave Ultrasound Imaging System
Treatment: Devices - Philips Lumify Ultrasound System With L12-4 Linear Probe

Experimental: VxWave and Comparator Ultrasound - All participants undergo VxWave scanning followed by Philips Lumify scanning of the same arm during one study visit. The first 20 consecutive participants after Participant ID 030 who complete comparator acquisition also undergo a repeat Lumify scan after probe lift-off and at least two minutes of rest.


Treatment: Devices: VxWave Ultrasound Imaging System
Robotically controlled acquisition of duplex B-mode and Doppler ultrasound data of the upper-limb vasculature, excluding the hand. The participant rests the limb on the scan bed while the probe moves beneath it. Images are measured offline using VxView. VxWave scanning occurs before the comparator scan.

Treatment: Devices: Philips Lumify Ultrasound System With L12-4 Linear Probe
Qualified vascular-sonographer acquisition of ultrasound data from the same upper-limb vascular locations after VxWave scanning. Images are measured offline using OsiriX MD. The specified repeatability subset undergoes a separate repeat comparator acquisition after probe lift-off and at least two minutes of rest.
Intervention code [1] 0 0
Treatment: Devices
Description of the comparator or control
Control group

Outcomes
Primary outcome [1] 0 0
Inter-System Agreement in Arterial Diameter
Timepoint [1] 0 0
During the first study visit (Day 1; approximately 2 hours, or 2 hours 15 minutes with repeat comparator scanning).
Primary outcome [2] 0 0
Inter-System Agreement in Peak Systolic Velocity
Timepoint [2] 0 0
During the first study visit (Day 1; approximately 2 hours, or 2 hours 15 minutes with repeat comparator scanning).
Secondary outcome [1] 0 0
Successful VxWave Scan Completion
Timepoint [1] 0 0
During the VxWave scan at the first study visit (Day 1).
Secondary outcome [2] 0 0
Time Required to Complete VxWave Scanning
Timepoint [2] 0 0
During the VxWave scan at the first study visit (Day 1).
Secondary outcome [3] 0 0
Participant Comfort and Satisfaction With VxWave Scanning
Timepoint [3] 0 0
Immediately after the VxWave scan during the first study visit (Day 1).
Secondary outcome [4] 0 0
Repeatability of Comparator Arterial Diameter Measurements
Timepoint [4] 0 0
During the first study visit (Day 1); repeat comparator acquisition follows probe lift-off and at least two minutes of rest.
Secondary outcome [5] 0 0
Repeatability of Comparator Peak Systolic Velocity Measurements
Timepoint [5] 0 0
During the first study visit (Day 1); repeat comparator acquisition follows probe lift-off and at least two minutes of rest.

Eligibility
Key inclusion criteria
* Age 21 years or older and able to provide written informed consent.
* Complete upper limb(s).
Minimum age
21 Years
Maximum age
No limit
Sex
Both males and females
Healthy volunteers
Yes
Key exclusion criteria
* Unable to provide informed consent.
* Unable or unwilling to place the limb onto the VxWave scanning bed.
* Infection risk to site staff and/or other study participants.
* Open or healing wound on the study limb.
* Known abnormal upper-limb vascular anatomy that would make scanning at the protocol discrete locations infeasible.
* Known allergy to parabens present in standard ultrasound gels.
* Any other reason at the discretion of the Principal Investigator.
* Previous upper-limb vascular surgery.
* Highly dependent on medical care.
* Cognitive impairment or intellectual disability.

Vascular-anatomy and prior-surgery exclusions are assessed using self-reported history; review of medical records is not required for this assessment.

Study design
Purpose of the study
Other
Allocation to intervention
Not applicable
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
Not yet recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
15/11/2026
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
20/01/2027
Actual
Sample size
Target
85
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 0 0
Prince of Wales Private, A/Prof Shannon Thomas's Rooms (Recruitment and Enrollment Only) - Randwick
Recruitment hospital [2] 0 0
Vexev Pty Ltd - Surry Hills
Recruitment postcode(s) [1] 0 0
2031 - Randwick
Recruitment postcode(s) [2] 0 0
2010 - Surry Hills

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Vexev Pty Ltd
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Tam Nguyen
Address 0 0
Vexev Pty Ltd
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Michael Cartmill
Address 0 0
Country 0 0
Phone 0 0
+61 400 223 656
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
Individual participant data will be shared on request.
When will data be available (start and end dates)?
Available to whom?
On request.
Available for what types of analyses?
How or where can data be obtained?


What supporting documents are/will be available?

No Supporting Document Provided


Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results not provided in https://clinicaltrials.gov/study/NCT07916857