Study Evaluating the BD WavelinQ EndoAVF Device for Creating Arteriovenous Fistulas in Adults Requiring Dialysis

What this Trial Is About

Researchers are evaluating the BD WavelinQ EndoAVF System for creating arteriovenous fistulas AV fistulas in adults who need dialysis due to end-stage kidney disease. This prospective, single-group, multi-center post-market surveillance study aims to observe how well this device works and how safe it is when used in real-world patients who require dialysis access. Participants will have an AV fistula created using the WavelinQ EndoAVF System, which is a device designed to help form the connection between an artery and a vein needed for dialysis. The study focuses on patients already on dialysis or those expected to need dialysis within six months and involves follow-up assessments up to 24 months after the procedure to evaluate the fistulas function and any related serious events. During the study, participants will be regularly monitored through ultrasound and other imaging methods to measure fistula maturation and function at multiple time points from 2 weeks up to 24 months after the procedure. Researchers will track success rates of cannulation, patency of the fistula, any additional procedures needed, and safety outcomes. The total participation duration can extend up to two years to gather comprehensive data on the devices performance and patient outcomes.

Post-market Surveillance Study of the BD® WavelinQ™ EndoAVF System