Magnetic Gastro-Ileal or Gastro-Jejunal Diversion Study ("MGI/MGJ Study")

Korábbi kezelés

• 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.
• Underwent a surgery/intervention within the 30 days proceeding the study procedure
• Any scheduled surgical or interventional procedure planned within 30 days post-study procedure
• Any stroke/TIA within 6 months prior to informed consent
• Requires chronic anticoagulation therapy (except aspirin)
• Recent tobacco or nicotine product cessation; cessation ≤ 3 months prior to informed consent
• Currently participating in another clinical research study with an investigational drug or medical device

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 months
• History of substance abuse
• Unhealed ulcers, bleeding lesions, tumor, or any other lesion at target magnet deployment site
• 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)

Laborértékek

• A positive COVID-19 test prior to the study procedure, where indicated by local COVID-19 protocols for procedure/surgical clearance

Egyéb

• Use of injectable insulin
• Uncontrolled T2DM
• Plan to perform a sleeve gastrectomy and/or hiatal hernia repair and/or cholecystectomy with the investigational study gastro-ileal anastomosis procedure
• 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, including any significant congenital or acquired anomalies of the GI tract at or distal to the placement of the magnets.
• Expected MR imaging within a two-month window following the study procedure
• Any anomaly preventing/contraindicating endoscopic or laparoscopic access and procedures
• Unable to comply with the follow-up schedule and assessments

• 18-65 years of age, inclusive, at the time of informed consent
• BMI 30-50 kg/m2, inclusive with either (A) Type 2 Diabetes Mellitus (T2DM), defined as HbA1c ≥ 6.5%, or (B) Weight regain following previous sleeve gastrectomy (>12 months) and indicated for a gastro-ileal diversion; OR
• BMI 35-50 kg/m2, inclusive without previous sleeve gastrectomy, and where (A) Gastro-jejunal diversion is indicated for the first stage, of a 2-stage, one anastomosis gastric bypass (OAGB), or (B) Single anastomosis gastric bypass (SAGB), with the second stage gastric pouch stapling performed >12 months after the gastro-ileal diversion, and not part of the investigational study
• 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