Long-Term Safety and Performance Study of the EndoForce System for Hemodialysis Vascular Access in Adults with End Stage Renal Disease

What this Trial Is About

Researchers are collecting long-term safety and performance data on the EndoForce System, a device used to connect a hemodialysis graft to a vein in patients with End Stage Renal Disease ESRD. This observational study focuses on patients who require vascular access for hemodialysis. The device has been approved by the FDA and this study is not testing an experimental therapy or procedure. Participants will have an arteriovenous AV graft implanted using the EndoForce Connector for Endovascular Venous Anastomosis in the upper arm. Since this is an observational study, no new treatments are assigned, and the study monitors the real-world use of the approved device over time. During the 2-year follow-up, researchers will track outcomes such as the incidence of treatment-emergent adverse events, graft patency how long the graft stays open, interventions needed to maintain graft function, and successful device use immediately after the procedure. Participants will follow their usual dialysis schedule and attend follow-up visits to assess safety and device performance throughout the study period.

EndoForce Post Approval Study