Feasibility Assessment of the VxWave Device for Vascular Access ImagingCANSCANNCT06691672
Feasibility Study of Dialysis Clinic Semi-Autonomous Ultrasound Scanning Using the Vexev Ultrasound Imaging System for Arteriovenous Fistula Mapping Examinations. The CANSCAN Trial.
A study testing Robotic Tomographic ultrasound imaging of the arm vasculature. in people with Feasibility Assessment of the VxWave Device for Vascular Access Imaging, run by Vexev Pty Ltd at 1 site in United States.
Trial summary
Study to assess the feasibility of dialysis clinic staff to perform upper limb mapping ultrasound scans using the Vexev Ultrasound Imaging System. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Feasibility Assessment of the VxWave Device for Vascular Access Imaging
- What is being tested?
- Robotic Tomographic ultrasound imaging of the arm vasculature.
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Nov 2024to 15 May 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Referred to a study site for chronic renal replacement therapy OR referred to a study site for management of CKD.
- Able to understand the procedures and requirements of the study and provide written informed consent and authorization for protected health information disclosure.
- Greater than or equal to 21 years of age at the time of written informed consent.
Who cannot join
- Patients' unable to load arm into scanning bed (due to upper limb medical co-morbidities/injury).
- Patient has evidence of open or incompletely healed wounds on both arms. Patients with open or incompletely healed wounds on a single arm are not excluded - if the ipsilateral arm is not able to be scanned - contralateral arm may be scanned.
- Any acute or chronic condition that would limit the ability of the patient to participate in the study - in the opinion of the principal investigator.
- Previous vascular/vascular access surgery on both upper limbs. Patients with previous vascular/vascular access surgery on a single arm are not excluded- contralateral arm may be scanned.
- -
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Feasibility Study of Dialysis Clinic Semi-Autonomous Ultrasound Scanning Using the Vexev Ultrasound Imaging System for Arteriovenous Fistula Mapping Examinations.
Study to assess the feasibility of dialysis clinic staff to perform upper limb mapping ultrasound scans using the Vexev Ultrasound Imaging System.
- Being tested
- Robotic Tomographic ultrasound imaging of the arm vasculature.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Robotic Tomographic ultrasound imaging of the arm vasculature.Diagnostic test
Semi-autonomous robotic tomographic ultrasound imaging of the arm vasculature for vascular access creation mapping in CKD patients.
| Study group | Role | What they receive |
|---|---|---|
| Imaging Arm | Experimental | Not described Receives: Diagnostic Test: Robotic Tomographic ultrasound imaging of the arm vasculature. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Vascular Access Robotic Tomographic Ultrasound (RTU) Mapping Efficacy and Feasability
The proportion of RTU vascular mapping scans performed using the VxWave Vascular Ultrasound Imaging Device that are assessed by interventionalists to provide sufficient imaging data to determine vascular access options.
Measured: From enrollment to the end of viable assessment window at 90 days.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Nov 2024
- Study start20 Nov 2024
- Primary completion15 May 2025
- Study completion15 May 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Feasibility Assessment of the VxWave Device for Vascular Access 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
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vexev Pty Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- USRC Kidney Research
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06691672
- Sponsor's protocol ID
- CIP-3-20242468
- Acronym
- CANSCAN
- Status last verified
- May 2025
- First submitted
- 12 Nov 2024
- Last updated
- 18 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility Study of Dialysis Clinic Semi-Autonomous Ultrasound Scanning Using the Vexev Ultrasound Imaging System for Arteriovenous Fistula Mapping Examinations.
- ClinicalTrials.gov ID
- NCT06691672
- Acronym / sponsor ID
- CANSCAN / CIP-3-20242468
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Vexev Pty LtdIndustry (pharma, biotech, devices)
- Collaborators
- USRC Kidney Research
- Study start
- 20 Nov 2024 (actual)
- Primary completion
- 15 May 2025 (actual)
- Study completion
- 15 May 2025 (actual)
- First posted
- 15 Nov 2024 (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.
Study to assess the feasibility of dialysis clinic staff to perform upper limb mapping ultrasound scans using the Vexev Ultrasound Imaging System.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Imaging Arm | Experimental | Diagnostic Test: Robotic Tomographic ultrasound imaging of the arm vasculature. |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Referred to a study site for chronic renal replacement therapy OR referred to a study site for management of CKD.
- Able to understand the procedures and requirements of the study and provide written informed consent and authorization for protected health information disclosure.
- Greater than or equal to 21 years of age at the time of written informed consent.
Key exclusion criteria (5 listed)
- Patients' unable to load arm into scanning bed (due to upper limb medical co-morbidities/injury).
- Patient has evidence of open or incompletely healed wounds on both arms. Patients with open or incompletely healed wounds on a single arm are not excluded - if the ipsilateral arm is not able to be scanned - contralateral arm may be scanned.
- Any acute or chronic condition that would limit the ability of the patient to participate in the study - in the opinion of the principal investigator.
- Previous vascular/vascular access surgery on both upper limbs. Patients with previous vascular/vascular access surgery on a single arm are not excluded- contralateral arm may be scanned.
- -
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 |
|---|---|---|
| Robotic Tomographic ultrasound imaging of the arm vasculature.Semi-autonomous robotic tomographic ultrasound imaging of the arm vasculature for vascular access creation mapping in CKD patients. | Diagnostic test | Imaging Arm |
Primary outcome
Vascular Access Robotic Tomographic Ultrasound (RTU) Mapping Efficacy and Feasability
Time frame: From enrollment to the end of viable assessment window at 90 days.
The proportion of RTU vascular mapping scans performed using the VxWave Vascular Ultrasound Imaging Device that are assessed by interventionalists to provide sufficient imaging data to determine vascular access options.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 May 2025.
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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Robotic Tomographic ultrasound imaging of the arm vasculature. in people with Feasibility Assessment of the VxWave Device for Vascular Access Imaging, run by Vexev Pty Ltd at 1 site in United States.
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 3 inclusion and 5 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: finished, as of the sponsor's last update on 18 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Vascular Access Robotic Tomographic Ultrasound (RTU) Mapping Efficacy and Feasability (time frame: From enrollment to the end of viable assessment window at 90 days.). 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 18 May 2025.