Safety and Feasibility Study of the ColoSeal ICD System for Protecting Colon After Surgery in Adults with Rectal and Rectosigmoid Cancer

What this Trial Is About

This research aims to evaluate the safety and feasibility of the ColoSeal ICD System in adult patients diagnosed with rectal and rectosigmoid cancer who are undergoing surgery to remove part of the colon and create a colorectal anastomosis. The study is a prospective, multicenter, single-arm investigation designed to protect a damaged colon segment, such as a surgical anastomosis or a leak, from contact with fecal flow for up to 14 days after surgery. Participants will have surgery performed according to the surgeons preferred method. After the colorectal anastomosis is completed and leak testing confirms no leak, the ColoSeal ICD Device will be inserted transanally using a delivery system. The devices anchor is positioned in healthy bowel above the area needing protection. The external part of the device is secured to the skin and connected to a collection bag. The device will remain in place for about 10 days post-surgery, after which leak testing will be repeated before device removal. During the study, participants will be monitored through scheduled assessments including leak tests before device insertion and removal. Researchers will track device-related adverse events up to 90 days after the procedure, procedure success and time, device migration, occurrence of anastomotic leakage, need for ostomy surgery, and successful device removal. Follow-up visits and monitoring will ensure participant safety and data collection throughout the study period, which lasts until the study completion date in late 2026.

ColoSeal™ ICD System Safety and Feasibility Study