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Xeltis graft - Clinical Trial

¿Cuál es el Propósito de este estudio?

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.

¿Cuál es la Condición que se está estudiando?

End-stage renal disease (ESRD)

¿Quién puede participar en el Estudio?

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.

Grupo etario
Adultos

¿Qué Implica?

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.

Detalles del Estudio

Título Completo
Prospective, non-randomized staged pivotal clinical study to assess the safety and performance of the Xeltis Hemodialysis Access graft: Xeltis aXess US Pivotal
Investigador Principal
Tristen T. Chun, MD, MS
Cirujano vascular
Número de Protocolo
IRB: PRO00118388
NCT: NCT06494631
Fase
Fase N/A
ClinicalTrials.gov
Estado de inscripción
Pronto disponible para inscripción
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Contribuya a Duke Health