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Effect of Amplifi Vein Dilation System Treatment on Radiocephalic AVF Maturation-3

NCT07058610 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 19

Last updated 2026-01-02

No results posted yet for this study

Summary

This multi-phase clinical study evaluated the safety and performance of the Amplifi Vein Dilation System (Amplifi System) in subjects requiring arteriovenous fistula (AVF) creation. Conducted at a single site outside the United States, subjects were enrolled across multiple phases. The study focused on device-related safety, procedural success, percent change in vein dilation and AVF maturation outcomes.

Conditions

  • End-Stage Renal Disease Requiring Haemodialysis

Interventions

DEVICE

Amplifi Vein Dilation System

An investigational extracorporeal blood pump and catheter system designed to promote vein dilation prior to AVF creation.

Sponsors & Collaborators

  • Amplifi Vascular, Inc.

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-12-08
Primary Completion
2025-06-11
Completion
2025-06-11
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 NCT07058610 on ClinicalTrials.gov