DI Bio-fragmentable MAGNET Feasibility Study

The purpose of this clinical research study is to evaluate the feasibility of the GT Metabolic Solutions DI Bio-fragmentable Magnetic Anastomosis System (MAGNET System, DI Bio-fragmentable) for creation of a side-by-side anastomosis duodeno-ileostomy in obese adults.

Inclusion Criteria:18-65 years of age, inclusive, at the time of informed consentBMI 30-35 kg/m2Type 2 diabetes mellitus (T2DM), defined as HbA1c > 6.5%, without previous sleeve gastrectomy, and without plan to perform a concurrent sleeve gastrectomy.Agrees to refrain from any type of additional bariatric or reconstructive surgery that would affect body weight for the duration of the studyIf a child-bearing female, subject must commit to not becoming pregnant and agree to use contraception for the duration of the studyWilling and able to comply with protocol requirementsExclusion Criteria:Type 1 diabetesUse of injectable insulinUncontrolled T2DMPrevious sleeve gastrectomy procedure or plan to perform a sleeve gastrectomy with the duodeno-ileal anastomosis procedureUncontrolled hypertension, dyslipidemia or sleep apneaPrior intestinal, colonic or duodenal surgery, other than bariatricPrior surgery, trauma, prostheses, disease or genetic expression which prevent or contra-indicate the procedure, including scarring and abnormal anatomy.Refractory gastro-esophageal reflux disease (GERD)Barrett's diseaseHelicobacter pylori positive and/or active ulcer diseaseLarge hiatal herniaInflammatory bowel or colonic diverticulitis diseaseAny anomaly precluding orogastric access by gastroscope and catheters, and manipulation techniques.Implantable pacemaker or defibrillatorPsychiatric disorder, except well-controlled depression with medication for > 6 moHistory of substance abuseWoman who is either pregnant or breast feedingWoman of childbearing potential who does not agree to use an effective method of contraception.Any comorbidity or current status of subject's physiological fitness that in the surgeon's or anesthesiologist's opinion represents safety concerns that make the subject medically unfit for the procedure.Any anomaly preventing/contraindicating laparoscopic access and general laparoscopic proceduresHad surgical or interventional procedure within 30 days prior to procedureAny scheduled surgical or interventional procedure planned within 30 days post-procedureAny stroke/transient ischemic attack (TIA) within 6 months prior to consentRequires chronic anticoagulation therapy (except aspirin)Active infections requiring antibiotic therapy, unless resolved before undergoing the study procedureUnable to comply with the follow-up schedule and assessmentsRecent tobacco or nicotine product cessation within < 3 months prior to informed consentKnown allergies to the device components or contrast mediaLimited life expectancy due to terminal diseaseCurrently participating in another clinical research study with an investigational drug or medical deviceA positive Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2 or COVID-19) test prior to the study procedure in accordance with local COVID-19 protocolAny condition that, in the investigator's opinion, may preclude completion of follow-up assessments through Day 360 (e.g., a medical condition that may increase the risk associated with study participation or may interfere with interpretation of study results, inability to adhere to the visit schedule, or poor compliance with treatment regimen)