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

Korábbi kezelés

• 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
• 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
• 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

Más betegség

• Known or suspected allergy to silicone, nickel, titanium or Nitinol
• Participants with an acute diagnosis of obstructed or perforated colon cancer at the time of the Screening Visit
• History of recurrent small bowel obstructions.
• 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.

Laborértékek

• Uncontrolled diabetes (defined as HbA1c >10%)
• 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
• 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)

Egyéb

• BMI > 55 kg/m2
• Congenital or acquired anomalies of the GI tract, including atresia or malrotation that would inhibit passing of SFM magnet
• Contraindication to general anesthesia
• Breast-feeding, pregnant, or planning on becoming pregnant during the follow-up period
• Contraindication to general anesthesia
• Participant is not appropriate for inclusion in the clinical trial, per the medical opinion of the Principal Investigator

• 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 ≥1 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