Colospan is initiating a pivotal clinical prospective, multi-center, single-arm, open-label study designed to evaluate safety and performance profile of the CG-100 Intraluminal Bypass Device in patients undergoing colorectal surgery study.~Up to 137 patients (in total) will be enrolled in up to 12 sites in Europe, Israel and USA.~Study objectives Primary Objective: To evaluate the performance of the CG-100 Intraluminal Bypass Device, in reducing contact of fecal content with an anastomotic site in patients undergoing colorectal surgery (open, robotic, or laparoscopic) Secondary Objectives: To evaluate Performance in terms of clinical and radiological anastomotic leakage Successful positioning and maintenance of device position To assess the ease of the device's application and removal Safety: To assess the safety profile of the CG-100 Intraluminal Bypass Device.
The purpose of this study is to evaluate the CG-100 device, a single use, temporary intraluminal bypass device,intended to reduce contact of fecal content with an anastomotic site, following colorectal surgery (open or laparoscopic)