MagDI Canada Study

Launched by GT METABOLIC SOLUTIONS, INC. · Jun 19, 2024

Keywords

ClinConnect Summary

The MagDI Canada Study is a clinical trial that is investigating a new system called the MagDI System, which is designed to help with a specific type of weight loss surgery called a duodeno-ileal side-to-side anastomosis. This procedure is intended for people dealing with obesity and type 2 diabetes. The trial aims to assess how well the MagDI System works and how safe it is for participants who meet certain criteria.

To be eligible for this study, participants need to be between 18 and 65 years old and have a Body Mass Index (BMI) between 30 and 50. They should also have type 2 diabetes or have regained weight after previous weight loss surgeries. Throughout the study, participants will need to commit to follow-up visits and refrain from any other weight-related surgeries. If you or someone you know fits these criteria and is interested in learning more about the study, it could be a valuable opportunity to explore new treatment options for obesity and diabetes.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Between 18-65 years of age, at the time of informed consent.
• • 2. Body Mass Index (BMI) between 30-50 kg/m2
• 3. Meets one of the following criteria:
• • 1. Type 2 Diabetes Mellitus (T2DM; defined as HbA1c ≥ 6.5%) or weight regain following previous sleeve gastrectomy (≥ 12 months); OR
• • 2. Type 2 Diabetes Mellitus (T2DM; defined as HbA1c ≥ 6.5%) or weight regain following previous endoscopic sleeve gastroplasty (≥ 12 months); OR
• • 3. Type 2 Diabetes Mellitus (defined as HbA1c ≥ 6.5%) with a Body Mass Index between 30-35 and without previous sleeve gastrectomy and no plan to perform a concurrent sleeve gastrectomy.
• • 4. Participant agrees to refrain from any type of additional bariatric or reconstructive surgery that would affect body weight for the duration of the study.
• • 5. 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.
• Exclusion Criteria:
• • 1. Type 1 diabetes.
• • 2. Use of injectable insulin.
• • 3. Uncontrolled Type 2 Diabetes Mellitus (T2DM).
• • 4. Investigator plans to perform a sleeve gastrectomy with the duodeno-ileal anastomosis procedure.
• • 5. Uncontrolled hypertension, dyslipidemia or sleep apnea.
• • 6. Prior intestinal, colonic or duodenal surgery (other than bariatric).
• • 7. Prior surgery, trauma, prostheses, disease or genetic expression which prevent or contraindicate the procedure, including scarring and abnormal anatomy.
• • 8. Refractory gastro-esophageal reflux disease (GERD).
• • 9. Barrett's disease.
• • 10. Helicobacter pylori positive and/or active ulcer disease.
• • 11. Large hiatal hernia.
• • 12. Inflammatory bowel or colonic diverticulitis disease.
• • 13. Any anomaly precluding orogastric access by gastroscope and catheters, and manipulation techniques.
• • 14. Any anomaly preventing / contraindicating endoscopic or laparoscopic access and procedures.
• • 15. Implantable pacemaker or defibrillator.
• • 16. Psychiatric disorder, except well-controlled depression with medication for \> 6 months.
• • 17. History of substance abuse.
• • 18. 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).
• • 19. 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.
• • 20. Unhealed ulcers, bleeding lesions, tumor, or any other lesion at target Magnet deployment site.
• • 21. Expected need for Magnetic Resonance Imaging (MRI) within the first 2 months post-procedure.
• • 22. 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.
• • 23. Any stroke / Transient Ischemic Attack (TIA) 6 months prior to consent.
• • 24. Requires chronic anticoagulation therapy (except aspirin).
• • 25. Active infections requiring antibiotic therapy, unless resolved before undergoing the study procedure.
• • 26. Recent tobacco or nicotine product cessation 3 months prior to informed consent.
• • 27. Known allergies to the device components (including the biofragmentable material PGLA or similar compounds) or contrast media.
• • 28. Participants with comorbidities that are likely to result in a life expectancy of 12 months.
• • 29. 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.
• • 30. A positive COVID-19 test prior to the study procedure in accordance with local COVID-19 protocol.
• • 31. 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.