Comparison of VxWave and Standard Ultrasound Measurements of Blood Vessels in the Arm
NCT07916857, Not applicable, Not yet recruiting, Vexev Pty Ltd
Trial 10
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
| Field | Value | Source |
|---|---|---|
| Title | Comparison of VxWave and Standard Ultrasound Measurements of Blood Vessels in the Arm | ClinicalTrials.gov |
| NCT number | NCT07916857 | ClinicalTrials.gov |
| Status | Not yet recruiting | ClinicalTrials.gov |
| Phases | Not applicable | ClinicalTrials.gov |
| Enrollment | 85 participants, estimated | ClinicalTrials.gov |
| Lead sponsor | Vexev Pty Ltd | ClinicalTrials.gov |
| Conditions | Upper Limb Vascular Imaging | ClinicalTrials.gov |
| Interventions | VxWave Ultrasound Imaging System, Philips Lumify Ultrasound System With L12-4 Linear Probe | ClinicalTrials.gov |
| First posted | 2026-11-04 | ClinicalTrials.gov |
| Last updated | 2026-11-04 | ClinicalTrials.gov |
Registered outcomes 10
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description | Source |
|---|---|---|---|---|
| Primary | Inter-System Agreement in Arterial Diameter | 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. | ClinicalTrials.gov |
| Primary | Inter-System Agreement in Peak Systolic Velocity | 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. | ClinicalTrials.gov |
| Secondary | Successful VxWave Scan Completion | During the VxWave scan at the first study visit (Day 1). | 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). | ClinicalTrials.gov |
| Secondary | Time Required to Complete VxWave Scanning | During the VxWave scan at the first study visit (Day 1). | 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. | ClinicalTrials.gov |
| Secondary | Participant Comfort and Satisfaction With VxWave Scanning | Immediately after the VxWave scan during the first study visit (Day 1). | 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. | ClinicalTrials.gov |
| Secondary | Repeatability of Comparator Arterial Diameter Measurements | During the first study visit (Day 1); repeat comparator acquisition follows probe lift-off and at least two minutes of rest. | 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. | ClinicalTrials.gov |
| Secondary | Repeatability of Comparator Peak Systolic Velocity Measurements | During the first study visit (Day 1); repeat comparator acquisition follows probe lift-off and at least two minutes of rest. | 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. | ClinicalTrials.gov |
| Other | Percentage of Scanned Participants With at Least One Device Deficiency | During the study scanning visit (Day 1). | 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. | ClinicalTrials.gov |
| Other | Percentage of Scanned Participants With at Least One Adverse Event | During the study visit (Day 1), with any adverse event followed until resolution or 60 days, whichever occurs first. | 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. | ClinicalTrials.gov |
| Other | Percentage of Scanned Participants With at Least One Adverse Device Effect | During the study visit (Day 1), with any adverse event followed until resolution or 60 days, whichever occurs first. | 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. | ClinicalTrials.gov |
Outcomes 0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as | Source |
|---|
Results by group 0
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units | Source |
|---|
Participant flow 0
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted | Source |
|---|
Adverse events 0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events | Source |
|---|
Adverse event totals 0
The totals the trial posted for each group.
| Total | Group | Affected | At risk | Source |
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Papers 0
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as | Source |
|---|
Grants 0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years | Source |
|---|
Trial comparisons 0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|
Tests 0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
| Test | Named as | Source |
|---|
Source 5
| Field | Value | Source |
|---|---|---|
| Release | trials-2026-11-12-0.4.0 | ClinicalTrials.gov |
| Release manifest SHA-256 | 0f4a8d8c48aee2a7573ae0fa94ecbeab70c1adbe449bbc95c424bc7d3e97b9d4 | ClinicalTrials.gov |
| Registry capture | 2026-11-12 | ClinicalTrials.gov |
| Results copy, AACT | 2026-03-23 | ClinicalTrials.gov |
| NIH clinical studies file | 2026-11-13 | ClinicalTrials.gov |
Release trials-2026-11-12-0.4.0
ClinicalTrials.gov's posted results, through CTTI's AACT: ClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299 ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
ClinicalTrials.gov: none stated ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
NIH RePORTER's clinical studies and project files: Public domain (NIH RePORTER)