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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-11-20

Study Completion Date

2025-05-15

Brief Summary

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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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Detailed Description

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Conditions

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Feasibility Assessment of the VxWave Device for Vascular Access Imaging

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Imaging Arm

Group Type EXPERIMENTAL

Robotic Tomographic ultrasound imaging of the arm vasculature.

Intervention Type DIAGNOSTIC_TEST

Semi-autonomous robotic tomographic ultrasound imaging of the arm vasculature for vascular access creation mapping in CKD patients.

Interventions

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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.

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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.

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Minimum Eligible Age

21 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No