Trial Review

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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] 305951 0
VX001
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
arteriovenous fistulas for dialysis 324549 0
Condition category
Condition code
Cardiovascular 322016 322016 0 0
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] 322344 0
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] 329772 0
Proportion of scans able to be completed with the Vexev Imaging system, as determined by adjucation by principal investigator.
Timepoint [1] 329772 0
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] 403722 0
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] 403722 0
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?
No
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
50
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 21252 0
Prince of Wales Private Hospital - Randwick
Recruitment postcode(s) [1] 36125 0
2031 - Randwick

Funding & Sponsors
Funding source category [1] 310293 0
Commercial sector/Industry
Name [1] 310293 0
Vexev Pty Ltd
Country [1] 310293 0
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] 311410 0
None
Name [1] 311410 0
Address [1] 311410 0
Country [1] 311410 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 309956 0
Bellberry
Ethics committee address [1] 309956 0
123 Glen Osmond Rd, Eastwood SA 5063
Ethics committee country [1] 309956 0
Australia
Date submitted for ethics approval [1] 309956 0
30/07/2021
Approval date [1] 309956 0
27/10/2021
Ethics approval number [1] 309956 0
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 115982 0
Dr Shannon Thomas
Address 115982 0
Level 2, Outpatients A, Campus Centre Building Prince of Wales Public Hospital, 320 - 346 Barker Street, Randwick NSW 2031
Country 115982 0
Australia
Phone 115982 0
+61 02 9382 2113
Fax 115982 0
Email 115982 0
shannondthomas@gmail.com
Contact person for public queries
Name 115983 0
Mr Michael cartmill
Address 115983 0
Vexev Pty Ltd
54 Forveax Street, Surry Hills
2010 NSW
Country 115983 0
Australia
Phone 115983 0
+61 400223656
Fax 115983 0
Email 115983 0
michael@vexev.com
Contact person for scientific queries
Name 115984 0
Mr Michael cartmill
Address 115984 0
Vexev Pty Ltd
54 Forveax Street, Surry Hills
2010 NSW
Country 115984 0
Australia
Phone 115984 0
+61 400223656
Fax 115984 0
Email 115984 0
michael@vexev.com

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
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.