The primary objective of this trial is to investigate the safety and effectiveness of the Megagon 28.5mm SFM system plus OTOLoc when used to create a colo-colonic and colorectal anastomosis 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 Colo-colonic or colo-rectal (with anastomosis above the peritoneal reflection) 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
Known or suspected allergy to silicone, nickel, titanium or Nitinol
BMI > 55 kg/m2
Uncontrolled diabetes (defined as HbA1c >10%)
Congenital or acquired anomalies of the GI tract, including atresia or malrotation that would inhibit passing of SFM magnet
Single group
Megagon Self-Forming Magnet
DeviceMegagon Self-Forming Magnet
Primary Endpoint
The study's primary endpoint (patient success) is defined as successful anastomosis created with the Megagon SFM without placement procedure, device or target anastomosis-related reoperation through 30 days.
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This trial is not recruiting at the moment. You can still explore other options:
