NCT06329310

Xeltis Hemodialysis Access (aXess) Conduit: aXess-E Study

Prospective, Non-randomized Feasibility Study to Confirm the Safety and Performance of the Xeltis Hemodialysis Access Conduit: aXess-E Study

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: Xeltis · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

A prospective, single arm, non-randomized feasibility study to confirm the safety and performance of the Xeltis Hemodialysis Access conduit, aXess-E, in subjects older than 18 years with end-stage renal disease, who plan to undergo hemodialysis for at least the first 6 months after study access creation.

Conditions

• End Stage Renal Disease

Interventions

Type	Name	Description
DEVICE	aXess-E conduit	The aXess-E conduit is a sterile, regenerative biodegradable polymer-based vascular conduit, consisting of a tubular structure with a 6mm inner diameter. It is comprised of a highly porous polymer matrix and an embedded electropolished nitinol reinforcement layer (Strain Relief System). The aXess-E conduit is able to support both straight and loop configurations and may be implanted in the upper arm and forearm.

Timeline

• Start date: 2024-12-16
• Primary completion: 2025-12-01
• Completion: 2026-12-01
• First posted: 2024-03-25
• Last updated: 2025-04-04

Locations

2 sites across 2 countries: Portugal, Serbia