A Study to Evaluate the Safety and Effectiveness of Voyagers Access Device for Patients Undergoing Routine Hemodialysis Access Cannulation Trial II

What this Trial Is About

The trial investigates the safety and effectiveness of Voyager Biomedicals Access Device designed to help patients undergoing routine hemodialysis by facilitating the cannulation of arteriovenous fistulas AVFs. This pivotal, interventional, single-arm, open-label study aims to support FDA clearance of the device by assessing its ability to improve access during dialysis and ensure patient safety. The study addresses challenges where AVFs are difficult to cannulate due to depth or accessibility issues and evaluates the device as a potential alternative to other surgical methods. Participants will have the VenaSure device surgically implanted at the dialysis access site, tailored to their clinical needs. Depending on vascular access conditions, one or two devices may be implanted to assist arterial andor venous cannulation. After implantation, patients will be observed for 6 weeks to allow healing. Following this, they will be monitored for 36 months while undergoing routine hemodialysis to assess the devices long-term performance and safety. During the study, participants will have regular follow-up visits to monitor healing, device function, and any adverse effects. Researchers will collect data on the devices ability to facilitate cannulation at 6 months and evaluate safety outcomes at 12 months and beyond. The study lasts approximately 48 to 60 months from enrollment until data collection is complete. Patients exit the study after the final visit with no ongoing device-related safety concerns.

Access Cannulation Trial II