Feasibility Study of Dialysis Clinic Semi-Autonomous Ultr... | NCT06691672

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

NCT06691672

Sponsor

Vexev Pty Ltd

Status

Completed

Last Update Posted

May 18, 2025Actual

Enrollment

120Actual

Phase

Not Applicable

Conditions

Feasibility Assessment of the VxWave Device for Vascular Access Imaging

Interventions

Robotic Tomographic ultrasound imaging of the arm vasculature.

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Status Module

Record Verification Date

May 2025

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 20, 2024Actual

Primary Completion Date

May 15, 2025Actual

Completion Date

May 15, 2025Actual

First Submitted Date

Nov 12, 2024

First Submission Date that Met QC Criteria

Nov 13, 2024

First Posted Date

Nov 15, 2024Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 15, 2025

Last Update Posted Date

May 18, 2025Actual

Name	Class
USRC Kidney Research	NETWORK

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

120Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Imaging Arm	Experimental		Diagnostic Test: Robotic Tomographic ultrasound imaging of the arm vasculature.

Interventions

Name	Type	Description	Arm Group Labels	Other Names
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.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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.

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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.

-

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

21 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided