Flexagon Plus OTOLoc Colon Anastomosis in Patients Undergoing Surgery

This is a prospective, multi-center, single-arm clinical study to evaluate the GI Windows Flexagon Self Forming Magnet Anastomosis plus OTOLoc for creating Ileo-colic and Colo-colonic anastomoses in participants undergoing colon surgery.

Inclusion criteria

• Aged 22 years or older at screening
• Candidate for surgery requiring Right Hemicolectomy or Sigmoid / Low Anterior resection (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
• All cancer patients must have completed chemotherapy ≥2 months prior to procedure
• Lives, and intends to remain, within a 300 kilometers 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 that would inhibit passing of SFM magnet
• 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 that may suggest difficulty during endoscopic delivery of magnets
• Any previous major surgery on the stomach, duodenum, hepatobiliary tree, pancreas, Whipple or right colon
• History of recurrent small bowel obstructions.
• 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
• Congestive heart failure with ejection fraction <35% or clinically significant arrhythmia (any rhythm disturbances except sinus tachycardia, sinus bradycardia or a sinus rhythm with premature atrial or ventricular complexes)
• Decompensated chronic obstructive lung disease
• Active or suspected infection at the surgical site or a CDC Class 3/contaminated or Class 4/dirty-infected surgical wound.
• 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
• Contraindication to general anesthesia
• Participant is not appropriate for inclusion in the clinical trial, per the medical opinion of the Principal Investigator