Feasibility Assessment of the VxWave Device for Vascular Access Imaging
Conditions
Brief summary
Study to assess the feasibility of dialysis clinic staff to perform upper limb mapping ultrasound scans using the Vexev Ultrasound Imaging System.
Interventions
DIAGNOSTIC_TESTRobotic Tomographic ultrasound imaging of the arm vasculature.
Semi-autonomous robotic tomographic ultrasound imaging of the arm vasculature for vascular access creation mapping in CKD patients.
Sponsors
USRC Kidney Research
Vexev Pty Ltd
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
21 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Referred to a study site for chronic renal replacement therapy OR referred to a study site for management of CKD. 2. Able to understand the procedures and requirements of the study and provide written informed consent and authorization for protected health information disclosure. 3. Greater than or equal to 21 years of age at the time of written informed consent.
Exclusion criteria
1. Patients' unable to load arm into scanning bed (due to upper limb medical co-morbidities/injury). 2. 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. 3. 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. 4. 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. \-
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Vascular Access Robotic Tomographic Ultrasound (RTU) Mapping Efficacy and Feasability | From enrollment to the end of viable assessment window at 90 days. | 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. |
Countries
United States
Outcome results
None listed