MagDI Diversion Feasibility Study

Korábbi kezelés

• Previous sleeve gastrectomy procedure or plan to perform a sleeve gastrectomy with the duodeno-ileal anastomosis procedure
• Prior intestinal, colonic or duodenal surgery, other than bariatric
• Prior surgery, trauma, prostheses, disease or genetic expression which prevent or contra-indicate the procedure, including scarring and abnormal anatomy.
• Had surgical or interventional procedure within 30 days prior to procedure
• Any scheduled surgical or interventional procedure planned within 30 days post-procedure
• Any stroke/transient ischemic attack (TIA) within 6 months prior to consent
• Requires chronic anticoagulation therapy (except aspirin)
• Recent tobacco or nicotine product cessation within < 3 months prior to informed consent
• Currently participating in another clinical research study with an investigational drug or medical device
• A 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 protocol

Más betegség

• Type 1 diabetes
• Uncontrolled hypertension, dyslipidemia or sleep apnea
• Refractory gastro-esophageal reflux disease (GERD)
• Barrett's disease
• Helicobacter pylori positive and/or active ulcer disease
• Inflammatory bowel or colonic diverticulitis disease
• Psychiatric disorder, except well-controlled depression with medication for > 6 mo
• History of substance abuse
• Active infections requiring antibiotic therapy, unless resolved before undergoing the study procedure
• Known allergies to the device components or contrast media
• Limited life expectancy due to terminal disease
• Any 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)

Egyéb

• Use of injectable insulin
• Uncontrolled T2DM
• Large hiatal hernia
• Any anomaly precluding orogastric access by gastroscope and catheters, and manipulation techniques.
• Implantable pacemaker or defibrillator
• Woman who is either pregnant or breast feeding
• Woman 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 procedures
• Unable to comply with the follow-up schedule and assessments

• 18-65 years of age, inclusive, at the time of informed consent
• BMI 30-35 kg/m2
• Type 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 study
• If a child-bearing female, subject must commit to not becoming pregnant and agree to use contraception for the duration of the study
• Willing and able to comply with protocol requirements