RecruitingNot ApplicableNCT06467955

MagDI Canada Study

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)

Sponsor

GT Metabolic Solutions, Inc.

Enrollment

60 participants

Start Date

May 10, 2024

Study Type

INTERVENTIONAL

Conditions

Obesity Type 2 Diabetes

Summary

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.

Eligibility

Min Age: 18 YearsMax Age: 65 Years

Plain Language Summary

Simplified for easier understanding

This Canadian study is testing a magnetic device (MagDI) designed to help people who have type 2 diabetes and obesity, or who have regained weight after a previous weight loss procedure. **You may be eligible if...** - You are 18 to 65 years old with a BMI between 30 and 50 - You have type 2 diabetes (HbA1c of 6.5% or higher) - You have regained weight after a previous sleeve gastrectomy or endoscopic sleeve gastroplasty (done at least 12 months ago) - OR you have type 2 diabetes with a BMI between 30-35 and have not had prior sleeve gastrectomy **You may NOT be eligible if...** - You are outside the age range of 18-65 - Your BMI is below 30 or above 50 - You do not have type 2 diabetes or weight regain after a prior procedure - You are planning additional weight loss surgery during the study Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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