Evaluating the Safety and Effectiveness of the Flex Robotic System for the Surgical Removal of Colorectal Lesions

This clinical trial assesses the safety and effectiveness of a new device called the Flex Robotic System in the surgical removal (resection) of colorectal lesions. When an area of abnormal tissue called a lesion is found in the colon or rectum, it is often not known if the lesion is cancerous or non-cancerous. Recommendation to remove the lesion may be made. Current methods of resection can be challenging and time-consuming. The Flex Robotic System is a new device that provides a stable working environment, better ability to grasp and cut lesions, and better tissue handling when performing a resection. The Flex Robotic system may be more effective at removing colorectal lesions than standard resection techniques.

Inclusion Criteria:Age >= 22 years (minimum age approved for use)Polypoid (0-Is) and non-polypoid (0-IIa, 0-IIb and 0-IIc) lateral spreading lesions according to Paris classificationColorectal lesions situated between 5 and 15 cm from the dentate lineColorectal mucosal lesions ranging from 1.5 to 7 cm in maximum diameterColorectal subepithelial lesions < 2 cm in sizeAbsence of uncorrectable bleeding disorder or coagulopathyPlatelet count > 50,000International normalized ratio (INR) < 1.5Ability to give informed consentExclusion Criteria:Inability to receive general anesthesiaPresence of medical conditions for which a transanal approach is contraindicated (e.g., anal stricture, radiation proctopathy)Excavated (0-III) colorectal lesions according to Paris classificationSuboptimal colon preparationClinical discretion of the provider