Early Feasibility Study of the Velocity™ Percutaneous Arterio-Venous Fistula System for Creating Hemodialysis Vascular Access
NCT06712251 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 20
Last updated 2025-08-17
Summary
The Velocity Percutaneous Arterio-Venous System is a minimally invasive method of creating hemodialysis vascular access. The study aims to understand clinical efficacy and initial clinical safety data of the device.
Conditions
- Chronic Kidney Disease Requiring Hemodialysis
- End Stage Renal Disease (ESRD)
Interventions
- DEVICE
-
Velocity pAVF System
The Velocity Percutaneous Arterio-Venous Fistula System consists of a percutaneous method designed to create an arteriovenous fistula for hemodialysis vascular access.
Sponsors & Collaborators
-
Venova Medical
lead INDUSTRY
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Max Age
- 80 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2025-01-08
- Primary Completion
- 2025-05-15
- Completion
- 2027-01-04
- FDA Device
- Yes
Countries
- United States
Study Locations
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