NCT04898153

First-in-Human (FIH) Study of the Xeltis Hemodialysis Access Graft

First-in-Human (FIH) Study of the Xeltis Hemodialysis Access Graft (aXess)

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

Summary

A feasibility study is to assess the preliminary safety and performance of the Xeltis hemodialysis access (aXess) graft.

Detailed description

A prospective, single arm, non-randomized FIH feasibility study to evaluate the preliminary safety and performance of the Xeltis hemodialysis access graft 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, and are deemed not suitable for fistula creation by the operating surgeon.

Conditions

• End Stage Renal Disease
• End Stage Renal Failure on Dialysis

Interventions

Type	Name	Description
DEVICE	aXess	Patients will be implanted with one Xeltis hemodialysis access device (aXess) in the arm

Timeline

• Start date: 2021-06-10
• Primary completion: 2023-03-24
• Completion: 2027-09-01
• First posted: 2021-05-24
• Last updated: 2025-07-10

Locations

6 sites across 4 countries: Belgium, Italy, Latvia, Lithuania