MagDI Australia Study

Korábbi kezelés

• Prior intestinal, colonic or duodenal surgery (other than bariatric).
• Prior surgery, trauma, prostheses, disease or genetic expression which prevent or contraindicate the procedure, including scarring and abnormal anatomy.
• Any surgical or interventional procedure (including planned and/or scheduled) within the period of 30 days prior to and 30 days following the study procedure.
• Any stroke/TIA ≤ 6 months prior to consent.
• Requires chronic anticoagulation therapy (except aspirin).
• Recent tobacco or nicotine product cessation ≤ 3 months prior to informed consent.
• Currently participating in an investigational drug or another device study that has not reached its primary endpoint: Note: Studies requiring extended follow-up for products that were investigational, but have since become commercially available, are not considered investigational trials.
• A positive COVID-19 test prior to the study procedure in accordance with local COVID-19 protocol.

Más betegség

• Type 1 diabetes.
• Uncontrolled Type 2 Diabetes Mellitus (T2DM).
• 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 (including the biofragmentable material PGLA or similar compounds) or contrast media.
• Presence of other anatomic or comorbid conditions, or other medical, social or psychological conditions that, in the investigator's opinion, could limit the participant's ability to participate in the clinical investigation or to comply with follow-up requirements, or impact the scientific soundness of the clinical investigation results.

Életkor

• Pregnant, lactating, or planning pregnancy during the clinical investigation. Note: Female participants of childbearing age must agree to use safe contraception (e.g., intrauterine devices, hormonal contraceptives: contraceptive pills, implants, transdermal patches hormonal vaginal devices, injections with prolonged release).

Egyéb

• Use of injectable insulin.
• Investigator plans to perform a sleeve gastrectomy with the duodeno-ileal anastomosis procedure.
• Large hiatal hernia.
• Any anomaly precluding orogastric access by gastroscope and catheters, and manipulation techniques.
• Any anomaly preventing / contraindicating endoscopic or laparoscopic access and procedures.
• Implantable pacemaker or defibrillator.
• Any comorbidity or current status of participant's physiological fitness that in the surgeon's or anesthesiologist's opinion represents safety concerns that make the participant 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 need for Magnetic Resonance Imaging (MRI) within the first 2 months post-procedure.
• Participants with comorbidities that are likely to result in a life expectancy of ≤ 12 months.

• Between 18-65 years of age, at the time of informed consent.
• Body Mass Index (BMI) between 30-50 kg/m2
• Meets one of the following criteria:
  • Type 2 Diabetes Mellitus (T2DM; defined as HbA1c ≥ 6.5%) following previous sleeve gastrectomy (≥ 12 months); OR
  • Type 2 Diabetes Mellitus (T2DM; defined as HbA1c ≥ 6.5%) without previous sleeve gastrectomy and without plan to perform a concurrent sleeve gastrectomy.
  • Weight regain following previous sleeve gastrectomy (≥ 12 months).
• Participant agrees to refrain from any type of additional bariatric or reconstructive surgery that would affect body weight for the duration of the study.
• Participant has been informed of the nature of the study and agrees to its provisions, complying with study required testing, medications, follow-up visits, and has provided written informed consent.
• Participant is indicated for, and has agreed to, a bariatric procedure involving a duodenal ileal anastomosis. The participant has also undergone the site standard of care evaluation for this type of procedure, which is expected to involve clinical assessments over a period of time by a multidisciplinary team and may include, but is not limited to, the following: screening for surgical safety, interviews to determine if the participant understands the procedure and post-operative demands, and whether the participant has the necessary social supports in place to help manage outcomes.