Phase
Condition
N/ATreatment
Small Bowel Anastomosis with Flexagon SFM Device with OTOLoc
Clinical Study ID
Ages > 22 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Aged 22 years or older at screening
Candidate for laparoscopic small bowel surgery requiring small bowel anastomosiswith 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 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 malrotation
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 endoscopy
Any previous major surgery on the stomach, duodenum, hepatobiliary tree (excludinglaparoscopically removed gallbladder or prior sleeve gastrectomy), pancreas or rightcolon
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
Active H. pylori infection
Active or suspected infection at the surgical site or a CDC Class 3/contaminated orClass 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-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
Subject 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
Fresno Community Hospital and Medical Center
Clovis, California 93611
United StatesSite Not Available
University of Miami
Coral Gables, Florida 33146
United StatesSite Not Available
Orlando Health
Orlando, Florida 32806
United StatesSite Not Available
Endeavor Health
Evanston, Illinois 60201
United StatesSite Not Available
Duke Regional Hospital
Durham, North Carolina 27704
United StatesSite Not Available
UT Health Houston
Houston, Texas 77401
United StatesSite Not Available
Seger Bariatrics and Metabolism, LLC
San Antonio, Texas 78229
United StatesSite Not Available
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