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

Not Applicable

Completed

• Conditions: Feasibility Assessment of the VxWave Device for Vascular Access Imaging

• Registration Number: NCT06691672
• Lead Sponsor: Vexev Pty Ltd

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-11-12
• Study First Submitted QC: 2024-11-13
• Study First Posted: 2024-11-15
• Study Start: 2024-11-20
• Status Verified: 2025-05
• Primary Completion: 2025-05-15
• Study Completion: 2025-05-15
• Last Update Submitted: 2025-05-15
• Last Update Posted: 2025-05-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 120

Inclusion Criteria

1. Referred to a study site for chronic renal replacement therapy OR referred to a study site for management of CKD.
2. Able to understand the procedures and requirements of the study and provide written informed consent and authorization for protected health information disclosure.
3. Greater than or equal to 21 years of age at the time of written informed consent.

Exclusion Criteria

1. Patients' unable to load arm into scanning bed (due to upper limb medical co-morbidities/injury).

2. 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.

3. 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.

4. 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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Vascular Access Robotic Tomographic Ultrasound (RTU) Mapping Efficacy and Feasability	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.

Trial Locations

Locations (1)

USRC E Houston Street; 🇺🇸 San Antonio, Texas, United States