Evaluating a new system for intestinal surgery to help with obesity and diabetes

Creation of Side-to-Side Compression Anastomosis Using the GT Metabolic MagDI System in Canada to Achieve Duodeno-Ileal Diversion in Adults With Obesity and With or Without Type 2 Diabetes Mellitus (MagDI Canada Study)

This study is testing a new magnetic system for intestinal surgery to see if it can help obese adults with type 2 diabetes manage their weight and improve their health.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 60 (estimated)
• Ages: 18 Years to 65 Years
• Sex: All
• Sponsor: GT Metabolic Solutions, Inc. (industry)
• Locations: 3 sites (Toronto, Ontario and 2 other locations)
• Trial ID: NCT06467955 on ClinicalTrials.gov

What this trial studies

The MagDI Canada study aims to assess the safety and performance of the MagDI System in patients undergoing a duodeno-ileal side-to-side anastomosis procedure, which is designed to aid in weight management and improve metabolic outcomes in obese adults with type 2 diabetes. This innovative approach seeks to replace traditional methods of creating intestinal connections, such as sutures and staples, with a magnetic system that may enhance recovery and efficacy. Participants will be monitored for safety and initial effectiveness of the procedure over the course of the study.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18-65 with a BMI between 30-50 and a diagnosis of type 2 diabetes or those who have experienced weight regain after previous bariatric procedures.

Not a fit: Patients who are outside the age range, have a BMI below 30 or above 50, or have not been diagnosed with type 2 diabetes may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide a less invasive surgical option for weight loss and improved metabolic health in patients with obesity and type 2 diabetes.

How similar studies have performed: While the use of magnetic systems in surgical procedures is relatively novel, similar studies have shown promise in improving surgical outcomes and patient recovery.

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.

Where this trial is running

Toronto, Ontario and 2 other locations

• University of Toronto — Toronto, Ontario, Canada (NOT_YET_RECRUITING)
• McGill University — Montreal, Quebec, Canada (NOT_YET_RECRUITING)
• Westmount Square Surgical Center — Westmount, Quebec, Canada (RECRUITING)

Study contacts

• Study coordinator: Lisa Griffin Vincent, PhD

Conditions: Obesity, Type 2 Diabetes, GT Metabolic, MagDI System, Magnetic Anastomosis