Open for Enrollment Soon
This study will open for enrollment soon. Please contact the study team for more information and check back frequently.

Xeltis graft - Clinical Trial

What is the Purpose of this Study?

If you join the study, doctors will place a small tube made from a man made material into your arm using normal surgery methods. You will also need to come to many study visits. These will happen at the beginning, on the day of the procedure, when you leave the hospital, and at 1, 3, 6, 12, 18, 24, 36, 48, and 60 months after the procedure.

What is the Condition Being Studied?

End-stage renal disease (ESRD)

Who Can Participate in the Study?

This study is for people who are 18 years or older and have end stage kidney disease. These people need hemodialysis, which is a treatment that cleans the blood. They can join the study if their doctor decides they are not good candidates for creating a fistula, which is a special connection made in the arm for dialysis.

Age Group
Adults

What is Involved?

The goal of this study is to see if a device called the aXess graft is safe and works well for people who have end stage kidney disease. This device helps patients receive hemodialysis, which is a treatment that cleans the blood when the kidneys can no longer do it on their own.

Study Details

Full Title
Prospective, non-randomized staged pivotal clinical study to assess the safety and performance of the Xeltis Hemodialysis Access graft: Xeltis aXess US Pivotal
Principal Investigator
Tristen T. Chun, MD, MS
Vascular Surgeon
Protocol Number
IRB: PRO00118388
NCT: NCT06494631
Phase
Phase N/A
ClinicalTrials.gov
Enrollment Status
Open for Enrollment Soon
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