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)
The objective of the MagDI Canada study is to evaluate the performance and safety of the MagDI System in eligible participants who are indicated for a duodeno-ileal (small bowel) side-to-side anastomosis procedure for partial intestinal diversion as one example of a small bowel clinical procedure requiring a side-to-side anastomosis. The secondary objective includes initial efficacy of the duodeno-ileal diversion using the MagDI System.
• 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%) or weight regain following previous sleeve gastrectomy (≥ 12 months); OR
⁃ Type 2 Diabetes Mellitus (T2DM; defined as HbA1c ≥ 6.5%) or weight regain following previous endoscopic sleeve gastroplasty (≥ 12 months); OR
⁃ 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.
• 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.