Trial Review

The ANZCTR website will be unavailable from 1pm until 3pm (AEDT) on Wednesday the 30th of October for website maintenance. Please be sure to log out of the system in order to avoid any loss of data.

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] 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
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
Trial website
Trial related presentations / publications
Public notes

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
[email protected]
Contact person for public queries
Name 115983 0
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
[email protected]
Contact person for scientific queries
Name 115984 0
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
[email protected]

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.