Clinical Trial

Xeltis Hemodialysis Access Graft: aXess Pivotal Study

Active, Not Recruiting
View on ClinicalTrials.gov →
Summary
A prospective, single arm, non-randomized pivotal study to evaluate the 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.
Protocol Amendment History 5 amendments
This ClinicalTrials.gov record has been amended 5 times since 2022-07-21; most recent amendment 2025-07-17.
Status change: Recruiting → Active, Not Recruiting 2025-01-17
Status change: Not Yet Recruiting → Recruiting 2022-12-12
Trial Details
NCT Number NCT05473299
Lead Sponsor Xeltis
Conditions End-stage Renal Disease
Enrollment 120 participants
Start Date 2022-11-04
Primary Completion 2025-06-23 (estimated)
Study Completion 2029-12-31 (estimated)
Updated on ClinicalTrials.gov 2025-07-18