None listed
Conditions
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 .
Interventions
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.
Sponsors
Vexev Pty Ltd
Study design
Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Diagnosis
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
12 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Referred for Ultrasound examination of surgical created arteriovenous fistula.
Exclusion criteria
Unable or unwilling to place arm onto vexev imaging system scan bed.
Outcome results
None listed