Feasibility Study of Dialysis Clinic Semi-Autonomous Ultrasound Scanning Using the Vexev Ultrasound Imaging System for Arteriovenous Fistula Mapping Examinations. The CANSCAN Trial.

NCT06691672 | Completed

• 1 other identifier: CIP-3-20242468
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

Study to assess the feasibility of dialysis clinic staff to perform upper limb mapping ultrasound scans using the Vexev Ultrasound Imaging System.

Conditions

Feasibility Assessment of the VxWave Device for Vascular Access Imaging

Outcome Measures

Primary Outcomes (1)

• 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.

  From enrollment to the end of viable assessment window at 90 days.

Study Arms (1)

Imaging Arm

EXPERIMENTAL

Diagnostic Test: Robotic Tomographic ultrasound imaging of the arm vasculature.

Interventions

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.

Imaging Arm

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Vexev Pty Ltd: lead
• USRC Kidney Research: collaborator

Study Sites (1)

USRC E Houston Street

San Antonio, Texas, 78220, United States

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 12, 2024
• First Posted: November 15, 2024
• Study Start: November 20, 2024
• Primary Completion: May 15, 2025
• Study Completion: May 15, 2025
• Last Updated: May 18, 2025

Record last verified: 2025-05

Locations

US (1)