Initial Safety of SFM Plus OTOLoc for Creating Side-to-side or End-to-side Colorectal Anastomoses

Exclusion Criteria

• •1. Known or suspected allergy to silicone, nickel, titanium or Nitinol
• •2. BMI \> 55 kg/m2
• •3. Uncontrolled diabetes (defined as HbA1c \>10%)
• •4. Congenital or acquired anomalies of the GI tract, including atresia or malrotation that would inhibit passing of SFM magnet
• •5. Participants with an acute diagnosis of obstructed or perforated colon cancer at the time of the Screening Visit
• •6. Any documented conditions for which endoscopy and/or laparoscopy would be contraindicated or history of previous failed endoscopy that may suggest difficulty during endoscopic delivery of magnets
• •7. History of recurrent small bowel obstructions.
• •8. Coagulation deficiency not normalized by medical treatment or platelet count \<50,000/µL
• •9. Known moderate to severe renal disease (eGFR \< 44 milliliters per minute per 1.73m2) or ongoing dialysis
• •10. Hyperkalemia / hypercoagulability or prior Venus Thromboembolism / Pulmonary Embolism
• •11. 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
• •12. 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)
• •13. Decompensated chronic obstructive lung disease
• •14. Active or suspected infection at the surgical site or a CDC Class 3/contaminated or Class 4/dirty-infected surgical wound.
• •15. Contraindication to general anesthesia
• •16. Breast-feeding, pregnant, or planning on becoming pregnant during the follow-up period
• •17. 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
• •18. Contraindication to general anesthesia
• •19. Participant is not appropriate for inclusion in the clinical trial, per the medical opinion of the Principal Investigator