Safety and Device Functionality of the Flexagon Self Forming Magnet Anastomosis Plus OTOLoc for Creating Ileo-colic, Colo-colonic and Colorectal Anastomoses in Patients Undergoing Surgical Procedures
The primary objective of this trial is to investigate the safety and effectiveness of the Flexagon 25mm SFM system plus OTOLoc when used to create a side-to-side Ileo-colic, Colo-colonic and side-to-side or end-to-side colorectal anastomoses in participants undergoing colon surgery. This will be evaluated via a composite safety/effectiveness endpoint of patient success defined as successful creation of the target anastomosis without placement procedure, device or target anastomosis related reoperation through 30 days.
• Aged 22 years or older at screening
• Candidate for surgery requiring Right of Left Hemicolectomy or Sigmoidectomy or Low Anterior resection with cardiac/medical clearance for surgery
• Able to understand and sign informed consent document
• American Society of Anesthesiologists (ASA) score \< IV at time of procedure
• All cancer patients must have completed chemotherapy ≥2 months prior to procedure
• Lives, and intends to remain, within a 150-mile radius of study center for the duration of the study
• Able to refrain from smoking during study follow-up period