Upper Limb Vascular ImagingNCT07916857
Comparison of VxWave and Standard Ultrasound Measurements of Blood Vessels in the Arm
A study testing VxWave Ultrasound Imaging System and Philips Lumify Ultrasound System With L12-4 Linear Probe in people with Upper Limb Vascular Imaging, run by Vexev Pty Ltd at 2 sites in Australia.
Trial summary
This study compares blood-vessel measurements obtained with the VxWave Ultrasound Imaging System and a standard ultrasound system operated by a qualified sonographer. Adults aged 21 years or older undergo scanning of the same arm with both systems at one study visit. Read more about this study
- Who is it for?
- Ages 21 years and olderHealthy volunteers can take part
- Conditions the study is for
- Upper Limb Vascular Imaging
- What is being tested?
- VxWave Ultrasound Imaging System and Philips Lumify Ultrasound System With L12-4 Linear Probe
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 85 participants
- Where
- 2 sitesAustralia
- Study dates
- 15 Nov 2026to 20 Jan 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age 21 years or older and able to provide written informed consent.
- Complete upper limb(s).
Who cannot join
- 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.
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- 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.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Australia2 sites
Prince of Wales Private, A/Prof Shannon Thomas's Rooms (Recruitment and Enrollment Only)
Randwick, New South Wales, 2031
Michael Cartmill, +61 400 223 656, michael@vexev.com
Vexev Pty Ltd
Surry Hills, New South Wales, 2010
Michael Cartmill, +61 400 223 656, michael@vexev.com
About this study
Official title: The VxWave Ultrasound Imaging System Upper Limb Clinical Performance Trial
This study compares blood-vessel measurements obtained with the VxWave Ultrasound Imaging System and a standard ultrasound system operated by a qualified sonographer. Adults aged 21 years or older undergo scanning of the same arm with both systems at one study visit. The researchers compare vessel diameter and blood-flow velocity at three specified locations in the upper arm and forearm. They also assess scan completion, scanning time, participant comfort, device deficiencies and adverse events. A subset undergoes a repeat standard ultrasound scan to assess the repeatability of the reference measurements.
Read the detailed description
This is an interventional, single-cohort, within-participant paired method-comparison study. Every participant undergoes VxWave scanning first, followed by Philips Lumify scanning of the same arm by a qualified vascular sonographer in a separate room. Three locations are examined: the brachial artery immediately proximal and immediately distal to the midpoint between the elbow crease and axillary fold, and the radial artery at the midpoint between the radial styloid process and elbow crease.
A qualified vascular sonographer who did not acquire the images performs all measurements offline using OsiriX MD for Lumify images and VxView for VxWave images. Random dataset identifiers conceal participant identity, pairing and repeat status. Measurements from the corresponding other-system dataset are unavailable during review. Imaging-system identity is not concealed by the use of separate software platforms.
The first 20 consecutive participants after Participant ID 030 who complete comparator acquisition undergo one repeat comparator scan after probe and gel removal and at least two minutes of rest. The first comparator acquisition remains the reference for primary agreement analysis; repeat acquisition is used only for reference-pathway repeatability.
Enrollment stops upon reaching either 50 participants with successful unilateral scans in the per-protocol set or 85 participants in the full analysis set. The first unilateral visit supplies the primary participant record. Optional contralateral-arm visits provide exploratory observations. No routine follow-up visit is scheduled; any adverse event is followed until resolution or 60 days, whichever occurs first.
Participants may provide consent and enroll at Prince of Wales Private or remotely. All ultrasound scanning and study imaging data acquisition are performed at Vexev Pty Ltd, Suite 501, 78 Kippax Street, Surry Hills NSW 2010. The Prince of Wales Private location is used for recruitment, consent and enrollment only; no scanning or imaging data acquisition takes place there.
- Conditions
- Upper Limb Vascular Imaging
- Being tested
- VxWave Ultrasound Imaging System, Philips Lumify Ultrasound System With L12-4 Linear Probe
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VxWave Ultrasound Imaging SystemDevice
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.
Philips Lumify Ultrasound System With L12-4 Linear ProbeDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| VxWave and Comparator Ultrasound | Experimental | 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. Receives: Device: VxWave Ultrasound Imaging System; Device: Philips Lumify Ultrasound System With L12-4 Linear Probe |
What is being measured
The primary outcome is the main question the study is designed to answer.
Inter-System Agreement in Arterial Diameter
Mean bias and 95% limits of agreement for VxWave minus comparator arterial diameter in millimetres at three pre-specified brachial/radial artery locations. Each location uses the mean of three diameter measurements. Multilevel Bland-Altman analysis accounts for measurements within participants, with 95% confidence intervals for bias and limits of agreement. The +/-0.5 mm margin is a descriptive benchmark and does not define a binary study-success criterion. Only diagnostic-quality measurements are included in agreement analysis.
Measured: During the first study visit (Day 1; approximately 2 hours, or 2 hours 15 minutes with repeat comparator scanning).
Inter-System Agreement in Peak Systolic Velocity
Mean percentage bias and 95% limits of agreement in symmetric relative percentage differences between VxWave and comparator peak systolic velocity at the three pre-specified brachial/radial artery locations. Mean of three representative peak systolic velocity measurements per location. Multilevel Bland-Altman analysis accounts for measurements within participants, with 95% confidence intervals for bias and limits of agreement. Absolute-scale agreement in cm/s is a sensitivity analysis. No PSV acceptance criterion is specified. Only diagnostic-quality measurements are included.
Measured: During the first study visit (Day 1; approximately 2 hours, or 2 hours 15 minutes with repeat comparator scanning).
Secondary outcomes (5)
Successful VxWave Scan Completion
Percentage of participants for whom VxWave completes the peripheral vascular imaging examination, with scan data judged by the reporting sonographer to be of diagnostic quality for measurement and able to confirm measurements. Reasons for failure include inability to perform both B-mode and Doppler measurements at two of the three discrete locations, or failure to complete scan data acquisition within a reasonable time (less than 55 minutes).
Measured: During the VxWave scan at the first study visit (Day 1).
Time Required to Complete VxWave Scanning
Elapsed time in minutes from initiation of the first acquisition run on the VxWave console to scan status complete on the final acquisition run, including time between runs. A scan may contain more than one acquisition run, including restarts after participant repositioning.
Measured: During the VxWave scan at the first study visit (Day 1).
Participant Comfort and Satisfaction With VxWave Scanning
Four questionnaire items assess overall comfort, satisfaction with scanning time, satisfaction with audible noise and overall satisfaction. Each item has five ordered response categories: Excellent, Very good, Good, Fair and Poor, with Excellent representing the most favorable response. Ordinal responses will be summarised using median/interquartile range or proportions. No composite score is specified in the protocol or supplied assessment form.
Measured: Immediately after the VxWave scan during the first study visit (Day 1).
Repeatability of Comparator Arterial Diameter Measurements
For the first 20 consecutive participants after Participant ID 030 who complete comparator acquisition, assess mean difference (bias), 95% limits of agreement and repeatability coefficient between first and repeat comparator arterial diameter measurements in millimetres at each pre-specified location. Multilevel Bland-Altman analysis accounts for measurements within participants, with 95% confidence intervals for bias and limits of agreement. The first comparator acquisition remains the reference for the primary endpoint; repeat acquisition is used for this secondary endpoint only.
Measured: During the first study visit (Day 1); repeat comparator acquisition follows probe lift-off and at least two minutes of rest.
Repeatability of Comparator Peak Systolic Velocity Measurements
For the same 20-participant repeatability cohort, assess mean difference (bias), 95% limits of agreement and repeatability coefficient between first and repeat comparator peak systolic velocity measurements, expressed as symmetric relative percentage differences, at each pre-specified location. Multilevel Bland-Altman analysis accounts for measurements within participants, with 95% confidence intervals. This descriptive endpoint characterises reference-pathway repeatability and does not define an acceptance test.
Measured: During the first study visit (Day 1); repeat comparator acquisition follows probe lift-off and at least two minutes of rest.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 2026
- Study start15 Nov 2026 (estimated)
- Primary completion15 Jan 2027 (estimated)
- Study completion20 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Upper Limb Vascular ImagingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Single-cohort, within-participant paired method-comparison study. Every participant undergoes VxWave scanning followed by Philips Lumify scanning of the same arm during the same visit. The repeatability subset undergoes an additional comparator acquisition. There is no allocation between intervention arms.
- Masking
- None (open label)
- Enrolment
- 85 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Vexev Pty Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Tam Nguyen, Principal investigator, Vexev Pty Ltd
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07916857
- Sponsor's protocol ID
- CIP-2
- Status last verified
- Oct 2026
- First submitted
- 29 Oct 2026
- Last updated
- 4 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual participant data will be shared on request.
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The VxWave Ultrasound Imaging System Upper Limb Clinical Performance Trial
- ClinicalTrials.gov ID
- NCT07916857
- Acronym / sponsor ID
- CIP-2
- Conditions
- Upper Limb Vascular Imaging
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 85 participants (estimated)
- Lead sponsor
- Vexev Pty LtdIndustry (pharma, biotech, devices)
- Study start
- 15 Nov 2026 (estimated)
- Primary completion
- 15 Jan 2027 (estimated)
- Study completion
- 20 Jan 2027 (estimated)
- First posted
- 4 Nov 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study compares blood-vessel measurements obtained with the VxWave Ultrasound Imaging System and a standard ultrasound system operated by a qualified sonographer. Adults aged 21 years or older undergo scanning of the same arm with both systems at one study visit. The researchers compare vessel diameter and blood-flow velocity at three specified locations in the upper arm and forearm. They also assess scan completion, scanning time, participant comfort, device deficiencies and adverse events. A subset undergoes a repeat standard ultrasound scan to assess the repeatability of the reference measurements.
Detailed description
This is an interventional, single-cohort, within-participant paired method-comparison study. Every participant undergoes VxWave scanning first, followed by Philips Lumify scanning of the same arm by a qualified vascular sonographer in a separate room. Three locations are examined: the brachial artery immediately proximal and immediately distal to the midpoint between the elbow crease and axillary fold, and the radial artery at the midpoint between the radial styloid process and elbow crease.
A qualified vascular sonographer who did not acquire the images performs all measurements offline using OsiriX MD for Lumify images and VxView for VxWave images. Random dataset identifiers conceal participant identity, pairing and repeat status. Measurements from the corresponding other-system dataset are unavailable during review. Imaging-system identity is not concealed by the use of separate software platforms.
The first 20 consecutive participants after Participant ID 030 who complete comparator acquisition undergo one repeat comparator scan after probe and gel removal and at least two minutes of rest. The first comparator acquisition remains the reference for primary agreement analysis; repeat acquisition is used only for reference-pathway repeatability.
Enrollment stops upon reaching either 50 participants with successful unilateral scans in the per-protocol set or 85 participants in the full analysis set. The first unilateral visit supplies the primary participant record. Optional contralateral-arm visits provide exploratory observations. No routine follow-up visit is scheduled; any adverse event is followed until resolution or 60 days, whichever occurs first.
Participants may provide consent and enroll at Prince of Wales Private or remotely. All ultrasound scanning and study imaging data acquisition are performed at Vexev Pty Ltd, Suite 501, 78 Kippax Street, Surry Hills NSW 2010. The Prince of Wales Private location is used for recruitment, consent and enrollment only; no scanning or imaging data acquisition takes place there.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Single-cohort, within-participant paired method-comparison study. Every participant undergoes VxWave scanning followed by Philips Lumify scanning of the same arm during the same visit. The repeatability subset undergoes an additional comparator acquisition. There is no allocation between intervention arms.
| Arm | Type | Receives |
|---|---|---|
| VxWave and Comparator Ultrasound | Experimental | Device: VxWave Ultrasound Imaging System, Device: Philips Lumify Ultrasound System With L12-4 Linear ProbeAll 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. |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Age 21 years or older and able to provide written informed consent.
- Complete upper limb(s).
Key exclusion criteria (11 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| VxWave Ultrasound Imaging SystemRobotically 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. | Device | VxWave and Comparator Ultrasound |
| Philips Lumify Ultrasound System With L12-4 Linear ProbeQualified 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. | Device | VxWave and Comparator Ultrasound |
Primary outcome
Inter-System Agreement in Arterial Diameter
Time frame: During the first study visit (Day 1; approximately 2 hours, or 2 hours 15 minutes with repeat comparator scanning).
Mean bias and 95% limits of agreement for VxWave minus comparator arterial diameter in millimetres at three pre-specified brachial/radial artery locations. Each location uses the mean of three diameter measurements. Multilevel Bland-Altman analysis accounts for measurements within participants, with 95% confidence intervals for bias and limits of agreement. The +/-0.5 mm margin is a descriptive benchmark and does not define a binary study-success criterion. Only diagnostic-quality measurements are included in agreement analysis.
Inter-System Agreement in Peak Systolic Velocity
Time frame: During the first study visit (Day 1; approximately 2 hours, or 2 hours 15 minutes with repeat comparator scanning).
Mean percentage bias and 95% limits of agreement in symmetric relative percentage differences between VxWave and comparator peak systolic velocity at the three pre-specified brachial/radial artery locations. Mean of three representative peak systolic velocity measurements per location. Multilevel Bland-Altman analysis accounts for measurements within participants, with 95% confidence intervals for bias and limits of agreement. Absolute-scale agreement in cm/s is a sensitivity analysis. No PSV acceptance criterion is specified. Only diagnostic-quality measurements are included.
5 secondary outcomes
Successful VxWave Scan Completion
Time frame: During the VxWave scan at the first study visit (Day 1).
Time Required to Complete VxWave Scanning
Time frame: During the VxWave scan at the first study visit (Day 1).
Participant Comfort and Satisfaction With VxWave Scanning
Time frame: Immediately after the VxWave scan during the first study visit (Day 1).
Repeatability of Comparator Arterial Diameter Measurements
Time frame: During the first study visit (Day 1); repeat comparator acquisition follows probe lift-off and at least two minutes of rest.
Repeatability of Comparator Peak Systolic Velocity Measurements
Time frame: During the first study visit (Day 1); repeat comparator acquisition follows probe lift-off and at least two minutes of rest.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Nov 2026.
- Individual participant dataSharing planned: Yes. Individual participant data will be shared on request.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Tam Nguyen principal investigator
Vexev Pty Ltd
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing VxWave Ultrasound Imaging System and Philips Lumify Ultrasound System With L12-4 Linear Probe in people with Upper Limb Vascular Imaging, run by Vexev Pty Ltd at 2 sites in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 4 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Michael Cartmill (+61 400 223 656, michael@vexev.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Inter-System Agreement in Arterial Diameter (time frame: During the first study visit (Day 1; approximately 2 hours, or 2 hours 15 minutes with repeat comparator scanning).). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Nov 2026.