NCT06467955

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)

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: GT Metabolic Solutions, Inc. · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Detailed description

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. The partial diversion of intestinal contents from the duodenum to the ileum via side-to-side duodeno-ileostomy is intended to facilitate weight management / loss in obese adults and improve metabolic outcomes in obese adults with type 2 diabetes mellitus (T2DM). Side-to-side anastomoses are currently created by sutures, staples, and anastomotic compression devices. The most common side-to-side anastomosis technique used today is stapling, requiring cutting of the intestines and staples remain behind in the body. Linear staplers are available in different sizes (e.g., 30mm, 45mm, 50mm, 60mm). A predicate for this side-to-side duodeno-ileostomy diversion procedure is the single-anastomosis duodeno-ileostomy (SADI) procedure.

Conditions

• Obesity
• Type 2 Diabetes

Interventions

Type	Name	Description
DEVICE	Magnet System, DI Biofragmentable	Anastomoses achieved by magnetic compression.

Timeline

• Start date: 2024-05-10
• Primary completion: 2026-02-01
• Completion: 2026-12-01
• First posted: 2024-06-21
• Last updated: 2025-12-23

Locations

3 sites across 1 country: Canada