Purpose of this Study
CopilotHere is a summary for a 5th grade audience, without contractions, apostrophes, or bullet points:
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.
Who Can Participate?
Eligibility
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 Range
18-110
Sex/Genders
Male (cisgender)
Female (cisgender)
Non-binary or gender fluid
Transgender male
Transgender female
Looking for Healthy Participants
No
What is Involved?
Description
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.
Locations
Duke Regional Hospital
Visit Timing
Weekdays
Compensation
No
Spanish Materials Available
No
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
Chun
Protocol Number
PRO00118388
NCT ID
NCT06494631
Phase
N/A
Enrollment Status
Pending Open to Enrollment