An interventional study of VxWave Ultrasound Imaging System and Philips Lumify Ultrasound System With L12-4 Linear Probe in Upper Limb Vascular Imaging, sponsored by Vexev Pty Ltd. Not yet recruiting at 2 sites in Australia. Open to participants aged 21 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-11-04.
Sponsored by Vexev Pty Ltd · Not applicable, Interventional, and Other
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.
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.
Vexev Pty Ltd is the lead sponsor of 2 studies on the registry; 1 is open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Vascular-anatomy and prior-surgery exclusions are assessed using self-reported history; review of medical records is not required for this assessment.
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Device: VxWave Ultrasound Imaging System · Device: Philips Lumify Ultrasound System With L12-4 Linear Probe
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.
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.
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.
Time frame: 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.
Time frame: During the first study visit (Day 1; approximately 2 hours, or 2 hours 15 minutes with repeat comparator scanning).
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).
Time frame: 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.
Time frame: 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.
Time frame: 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.
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
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.
Time frame: During the first study visit (Day 1); repeat comparator acquisition follows probe lift-off and at least two minutes of rest.
Percentage of Scanned Participants With at Least One Device Deficiency
100 multiplied by the number of unique scanned participants whose scan is associated with at least one VxWave device deficiency, divided by the total number of unique participants who undergo a scan. Include attempted scans regardless of successful completion or diagnostic image quality. Each participant is counted once, even if more than one deficiency or scan occurs. Device deficiencies include those identified before scan completion.
Time frame: During the study scanning visit (Day 1).
Percentage of Scanned Participants With at Least One Adverse Event
100 multiplied by the number of unique scanned participants who experience at least one adverse event (AE), divided by the total number of unique participants who undergo a scan. AEs are counted regardless of their relationship to the device or study procedure. Include attempted scans regardless of successful completion. Each participant is counted once, even if multiple AEs or scans occur. Device/procedure-related AEs are included in this overall AE measure and are also reported separately as adverse device effects.
Time frame: During the study visit (Day 1), with any adverse event followed until resolution or 60 days, whichever occurs first.
Percentage of Scanned Participants With at Least One Adverse Device Effect
100 multiplied by the number of unique scanned participants who experience at least one adverse device effect (ADE), divided by the total number of unique participants who undergo a scan. Per the protocol, an ADE is an AE related to the VxWave Ultrasound Imaging System or study procedure. Include attempted scans regardless of successful completion. Each participant is counted once, even if multiple ADEs or scans occur. ADEs are a subset of all AEs; the overall AE percentage and ADE percentage must not be added together.
Time frame: During the study visit (Day 1), with any adverse event followed until resolution or 60 days, whichever occurs first.
Plan to share: Yes — Individual participant data will be shared on request.
Access criteria: On request.
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From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
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