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

End Stage Renal Disease Clinical Trial

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

Clinical Trial Summary

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

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04898153
Study type Interventional
Source Xeltis
Contact
Status Active, not recruiting
Phase N/A
Start date June 10, 2021
Completion date September 2027
View Details
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