Functional Lumen Opening With Self-Forming Magnetic Anastomosis

This is a multicenter, pivotal study in which clinical outcomes will be prospectively evaluated for a minimum of 70 subjects undergoing anastomosis creation using the Flexagon SFM system plus OTOLoc.

Inclusion criteria

• Aged 22 years or older at screening
• Candidate for laparoscopic small bowel surgery requiring small bowel anastomosis 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
• Lives, and intends to remain, within a 185-mile radius of study center for the duration of the study
• Able to refrain from smoking during study follow-up period

Exclusion criteria

• 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
• Diagnosed with obstructed or perforated colon cancer
• Any documented conditions for which endoscopy and/or laparoscopy would be contraindicated or history of previous technically difficult or failed endoscopy
• Any previous major surgery on the stomach, duodenum, hepatobiliary tree (excluding laparoscopically removed gallbladder or prior sleeve gastrectomy), pancreas or right colon
• Coagulation deficiency not normalized by medical treatment or platelet count <50,000/µL
• Known moderate to severe renal disease (eGFR < 44 milliliters per minute per 1.73m2) or ongoing dialysis
• Hyperkalemia / hypercoagulability or prior Venus Thromboembolism / Pulmonary Embolism
• Immunocompromised (e.g., active treatment for malignancies, hematologic malignancy, on immunosuppressive therapy, moderate or severe primary immunodeficiency, advanced or untreated HIV, active treatment with high-dose corticosteroids (i.e., 20 or more mg of prednisone or equivalent per day when administered for 2 or more weeks prior to surgery) or other immunosuppressive or immunomodulatory agents
• Active H. pylori infection
• Active or suspected infection at the surgical site or a CDC Class 3/contaminated or Class 4/dirty-infected surgical wound.
• Obstructive Sleep Apnea on CPAP unless assessed and cleared by independent physician
• Contraindication to general anesthesia
• Breast-feeding, pregnant, or planning on becoming pregnant during the follow-up period
• Currently participating or has participated in another clinical trial within the past 30 days and is receiving/has received an investigational drug, device, or biologic agent
• Subject is not appropriate for inclusion in the clinical trial, per the medical opinion of the Principal Investigator