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Early Feasibility of the Velocity™ Percutaneous PAVF System

NCT05757726 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2025-03-19

No results posted yet for this study

Summary

An early feasibility study of the the initial safety and efficacy of the Velocity Percutaneous Arterio-Venous Fistula (pAVF) System when used to percutaneously create an arteriovenous fistula in patients with ESRD requiring hemodialysis vascular access.

Conditions

  • Arteriovenous Fistula

Interventions

DEVICE

Velocity pAVF system

A second generation percutaneous AVF device that creates an AVF between the proximal radial artery and cubital perforating vein.

Sponsors & Collaborators

  • Venova Medical

    lead INDUSTRY

Principal Investigators

  • Adrian Ebner, MD · Sanatorio Italiano

Study Design

Allocation
NA
Purpose
DEVICE_FEASIBILITY
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-02-14
Primary Completion
2023-11-15
Completion
2024-10-08
FDA Device
Yes

Countries

  • Paraguay

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05757726 on ClinicalTrials.gov