A Safety and Effectiveness Prospective Blinded Clinical Study to Validate xBar System as Monitoring Tool for Anastomotic Leaks Detection

What this Trial Is About

Researchers are evaluating the safety and effectiveness of the xBar system, a monitoring tool designed to detect post-operative anastomotic leaks in patients undergoing rectal or sigmoid resections with anastomosis. This pivotal, prospective, blinded, multi-center study involves about 190 participants scheduled for colorectal surgery without diversion. The clinical team is blinded to the xBar system's leak detection results to objectively assess its performance. The xBar system is an investigational device consisting of a surgical drain with embedded electrodes connected to a small electronic device that collects and relays data. During the surgery, the xBar device will be placed according to standard procedures, and data recording will continue for at least 3 days after surgery. All patients in the study will receive the xBar device, and safety and complication detection performance will be evaluated by comparing the clinical team's diagnoses with the system's data retrospectively. Participants will be monitored through the study period, which includes follow-up assessments for an average of one year to evaluate safety and performance outcomes. Researchers will measure severe leak rates comparable to standard care, successful device placement, and sensitivity and specificity of severe leak detection. The study involves safety monitoring and retrospective performance evaluation to determine the device's ability to detect complications after colorectal surgery.

A Safety and Effectiveness Prospective Blinded Clinical Study to Validate xBar System as Monitoring Tool for Anastomotic Leaks Detection