NCT07058610

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 19 (actual)
• Sponsor: Amplifi Vascular, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

The Amplifi System was used to promote vein dilation prior to AVF creation. Subjects with ESRD or CKD were treated across three phases of enrollment. The protocol incorporated learnings from earlier phases, including improvements to the device design and procedural protocols. This registration covers all phases of the study (Phase 1-3), with updates planned as new data becomes available.

Conditions

• End-Stage Renal Disease Requiring Haemodialysis

Interventions

Type	Name	Description
DEVICE	Amplifi Vein Dilation System	An investigational extracorporeal blood pump and catheter system designed to promote vein dilation prior to AVF creation.

Timeline

• Start date: 2020-12-08
• Primary completion: 2025-06-11
• Completion: 2025-06-11
• First posted: 2025-07-10
• Last updated: 2026-01-02

Locations

1 site across 1 country: Paraguay

Regulatory

• FDA-regulated device study