NCT06613724

Magnetic Duodeno-Ileal Chile Study

Creation of Side-to-Side Compression Anastomosis Using the GT Metabolic Solutions Magnet System, DI Biofragmentable (MagDI System) in Chile to Achieve Duodeno-Ileostomy Diversion in Adults With Obesity and With or Without Type 2 Diabetes Mellitus (MagDI Chile Study)

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 10 (actual)
• Sponsor: GT Metabolic Solutions, Inc. · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

The objective of the MagDI Chile Study is to evaluate the feasibility / performance, safety, and initial efficacy 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 (e.g., one example of a small bowel clinical procedure requiring a side-to-side anastomosis).

Detailed description

The objective of the MagDI Chile Study is to evaluate the feasibility / performance, safety, and initial efficacy 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 (e.g., one example of a small bowel clinical procedure requiring a side-to-side anastomosis). 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 and without 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 Mellitus (T2DM)

Interventions

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

Timeline

• Start date: 2024-10-14
• Primary completion: 2025-02-27
• Completion: 2025-12-04
• First posted: 2024-09-26
• Last updated: 2025-12-26

Locations

1 site across 1 country: Chile