Clinical Trial

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

Study acronym: aXess-FIH
Active, Not Recruiting
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Summary
A feasibility study is to assess the preliminary safety and performance of the Xeltis hemodialysis access (aXess) graft.
Protocol Amendment History 6 amendments
This ClinicalTrials.gov record has been amended 6 times since 2021-05-21; most recent amendment 2025-07-09.
Status change: Enrolling by Invitation → Active, Not Recruiting 2022-10-07
Status change: Recruiting → Enrolling by Invitation 2021-06-22
Status change: Not Yet Recruiting → Recruiting 2021-06-11
Trial Details
NCT Number NCT04898153
Lead Sponsor Xeltis
Conditions End Stage Renal Disease, End Stage Renal Failure on Dialysis
Enrollment 20 participants
Start Date 2021-06-10
Primary Completion 2023-03-24 (estimated)
Study Completion 2027-09 (estimated)
Updated on ClinicalTrials.gov 2025-07-10