Phase
Condition
N/ATreatment
Ileo-colic and colo-colonic Anastomosis with Flexagon SFM and OTOLoc
Clinical Study ID
Ages > 22 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Aged 22 years or older at screening
Candidate for surgery requiring Right Hemicolectomy or Sigmoid / Low Anteriorresection (with anastomosis above the peritoneal reflection) with cardiac/medicalclearance 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 theduration of the study
Able to refrain from smoking during study follow-up period
Exclusion
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 malrotationthat would inhibit passing of SFM magnet
Diagnosed with obstructed or perforated colon cancer
Any documented conditions for which endoscopy and/or laparoscopy would becontraindicated or history of previous technically difficult or failed endoscopythat 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 / PulmonaryEmbolism
Immunocompromised (e.g., active treatment for malignancies, hematologic malignancy,on immunosuppressive therapy, moderate or severe primary immunodeficiency, advancedor untreated HIV, active treatment with high-dose corticosteroids (i.e., 20 or moremg of prednisone or equivalent per day when administered for 2 or more weeks priorto surgery) or other immunosuppressive or immunomodulatory agents
Congestive heart failure with ejection fraction <35% or clinically significantarrhythmia (any rhythm disturbances except sinus tachycardia, sinus bradycardia or asinus 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 orClass 4/dirty-infected surgical wound.
Contraindication to general anesthesia
Breast-feeding, pregnant, or planning on becoming pregnant during the follow-upperiod
Currently participating or has participated in another clinical trial within thepast 30 days and is receiving/has received an investigational drug, device, orbiologic agent
Contraindication to general anesthesia
Participant is not appropriate for inclusion in the clinical trial, per the medicalopinion of the Principal Investigator
Study Design
Study Description
Connect with a study center
Mohak Hitech Specialty Hospital
Indore, Madhya Pradesh 454555
IndiaActive - Recruiting
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