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Completed

NCT Number: NCT06691672

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

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

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Key information

Age range

21 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

USRC E Houston Street

San Antonio, Texas, 78220, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

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Treatment and study plan

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.

Primary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Vexev Pty Ltd

Industry

Collaborators

  • USRC Kidney Research

Registry information

Official study title

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

Acronym: CANSCAN

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Nov 15, 2024
Registry last updated
May 18, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.