Clinical Trial

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

Study acronym: Amplifi FIH
Completed
View on ClinicalTrials.gov →
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.
Protocol Amendment History 1 amendment
This ClinicalTrials.gov record has been amended once since 2025-07-01.
Trial Details
NCT Number NCT07058610
Lead Sponsor Amplifi Vascular, Inc.
Conditions End-Stage Renal Disease Requiring Haemodialysis
Enrollment 19 participants
Start Date 2020-12-08
Primary Completion 2025-06-11 (estimated)
Study Completion 2025-06-11 (estimated)
Updated on ClinicalTrials.gov 2026-01-02