ANZCTR - Registration

Registering a new trial?

To achieve prospective registration, we recommend submitting your trial for registration at the same time as ethics submission.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers

Trial registered on ANZCTR

Registration number

ACTRN12622000194763

Ethics application status

Approved

Date submitted

1/12/2021

Date registered

4/02/2022

Date last updated

24/03/2024

Date data sharing statement initially provided

4/02/2022

Type of registration

Prospectively registered

Titles & IDs

Public title

Feasibility of automated ultrasound imaging using the Vexev Imaging System

Scientific title

Feasibility of automated tomographic ultrasound scanning of arteriovenous fistulas.

Secondary ID [1]

VX001

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

arteriovenous fistulas for dialysis

Condition category

Condition code

Cardiovascular

Diseases of the vasculature and circulation including the lymphatic system

Intervention/exposure

Study type

Interventional

Description of intervention(s) / exposure

Patients who choose to enrol in the study shall undergo imaging of their arteriovenous fistulas with the Vexev Imaging system in addition to their normal standard of care ultrasound scan. The additional procedure is expected to take less than 10minutes, with patients only undergoing the scan once in the study. The system will operated by Vexev engineering staff under the supervision of qualified sonographers or vascular surgeon. The study has a target enrolment number of 50.

Intervention code [1]

Diagnosis / Prognosis

Comparator / control treatment

The control treatment is a standard vascular ultrasound exam, performed as scheduled in clinic by qualified sonographer. The standard scan involves placing an ultrasound probe on the patients arm and capturing image and flow data. The scan usually takes 30-40mins.

Control group

Active

Outcomes

Primary outcome [1]

Proportion of scans able to be completed with the Vexev Imaging system, as determined by adjucation by principal investigator.

Timepoint [1]

All data will be assessed upon enrolment target of 50 patients, with interim analysis of the data performed at each new enrolment.

Secondary outcome [1]

Time taken to complete scan with the Vexev Imaging system, using timestamps from vexex imaging software, and manual time entry by study investigators.

Timepoint [1]

All data will be assessed upon enrolment target of 50 patients, with interim analysis of the data performed at each new enrolment.

Eligibility

Key inclusion criteria

Referred for Ultrasound examination of surgical created arteriovenous fistula.

Minimum age

12 Years

Maximum age

No limit

Sex

Both males and females

Can healthy volunteers participate?

Key exclusion criteria

Unable or unwilling to place arm onto vexev imaging system scan bed.

Study design

Purpose of the study

Diagnosis

Allocation to intervention

Non-randomised trial

Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)

Methods used to generate the sequence in which subjects will be randomised (sequence generation)

Masking / blinding

Open (masking not used)

Who is / are masked / blinded?

Intervention assignment

Single group

Other design features

Phase

Not Applicable

Type of endpoint/s

Statistical methods / analysis

Recruitment

Recruitment status

Not yet recruiting

Date of first participant enrolment

Anticipated

30/06/2024

Actual

Date of last participant enrolment

Anticipated

6/02/2025

Actual

Date of last data collection

Anticipated

28/02/2025

Actual

Sample size

Target

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

NSW

Recruitment hospital [1]

Prince of Wales Private Hospital - Randwick

Recruitment postcode(s) [1]

2031 - Randwick

Funding & Sponsors

Funding source category [1]

Commercial sector/Industry

Name [1]

Vexev Pty Ltd

Address [1]

54 Forveax Street Surry Hills
NSW 2010

Country [1]

Australia

Primary sponsor type

Commercial sector/Industry

Name

Vexev Pty Ltd

Address

54 Forveax Street Surry Hills
NSW 2010

Country

Australia

Secondary sponsor category [1]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Bellberry

Ethics committee address [1]

123 Glen Osmond Rd, Eastwood SA 5063

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

30/07/2021

Approval date [1]

27/10/2021

Ethics approval number [1]

No: 2021-08-952

Summary

Brief summary

The purpose of this study is to evaluate the functionality of the Vexev Robot Imaging System (VRIS) for arteriovenous fistula ultrasound scanning. 
Duplex ultrasound examinations are labour intensive and require highly skilled staff to perform, these staff are limited in the number of scans they are able to perform per day, and hence there are often issues of timely access to quality duplex ultrasound services. 
The VRIS is designed to autonomously perform high quality duplex ultrasound scans in a fraction of the time of a normal duplex sonography procedure. The VRIS is designed with the goal of outputting highly reproducible and accurate duplex ultrasound, which we hope will improve the ability for clinicians to map, monitor and intervene and hence increase AVF longevity.

Normal duplex ultrasound scans involve a medical professional placing an ultrasound probe on the patient’s limb then moving the probe to image the regions of interest.  In contrast the VRIS scan involves the patient placing their limb onto a scan bed and the ultrasound probe moving automatically, underneath the scan bed, to scan all regions of interest.   It is expected that the VRIS scan will require significantly less time to complete (10mins for VRIS vs ~45mins for normal duplex scan).  

The primary objective of this feasibility study is to evaluate the feasibility (as defined by the primary endpoints) of the VRIS for AVF ultrasound (US) scanning, performed in a specialist vascular imaging practice. 
This study does not involve evaluation(s) of the clinical efficacy of the VRIS. Study participants will be enrolled for scanning with the VRIS in the same visit as their scheduled clinically, standard of care, indicated AVF US mapping or surveillance exam. 

Secondary objectives are to measure the practicality and feasibility of VRIS for routine clinical use and to collect paired outcome data to assist with the development of the VRIS system .

Trial website

Trial related presentations / publications

Public notes

Re: Application No: 2021-08-952
Study Title: The VRIS AVF feasibility trial Feasibility of automated tomographic ultrasound scanning of arteriovenous fistulas.
Application Type: NEW
Type of Review: FULLBOARD

Committee Name/NHMRC Codes: A/ EC00372; B/ EC00419; C/ EC00430; D/ EC00444;
E/ EC00450; F/ EC00455; G/ EC00458; H/ EC00459; I/ EC00468; J/ EC00469; K/ EC00470; L/ EC00471.

Contacts

Principal investigator

Name

Dr Shannon Thomas

Address

Level 2, Outpatients A, Campus Centre Building Prince of Wales Public Hospital, 320 - 346 Barker Street, Randwick NSW 2031

Country

Australia

Phone

+61 02 9382 2113

Fax

[email protected]

Contact person for public queries

Name

Michael cartmill

Address

Vexev Pty Ltd
54 Forveax Street, Surry Hills
2010 NSW

Country

Australia

Phone

+61 400223656

Fax

[email protected]

Contact person for scientific queries

Name

Michael cartmill

Address

Vexev Pty Ltd
54 Forveax Street, Surry Hills
2010 NSW

Country

Australia

Phone

+61 400223656

Fax

[email protected]

Data sharing statement

Will individual participant data (IPD) for this trial be available (including data dictionaries)?

No/undecided IPD sharing reason/comment

What supporting documents are/will be available?

No Supporting Document Provided

Results publications and other study-related documents

Documents added manually

No documents have been uploaded by study researchers.

Documents added automatically

No additional documents have been identified.

Trial Review

Registering a new trial?

Documents added manually

Documents added automatically