NCT06232746

Magnetic Jejuno-Ileal Diversion Study ("MJI Study")

Creation of Side-to-Side Compression Anastomosis Using the GT Metabolic Solutions DI Biofragmentable Magnetic Anastomosis System (Magnet System, DI Biofragmentable) to Achieve Jejuno-Ileal Diversion in Adults With Obesity and Type 2 Diabetes Mellitus: MJI Study

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 9 (actual)
• Sponsor: GT Metabolic Solutions, Inc. · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this clinical research study is to evaluate the feasibility/performance, safety and initial efficacy of the GT Metabolic Solutions DI Biofragmentable Magnetic Anastomosis System (Magnet System, DI Biofragmentable and hereafter referred to as the DI Magnet System) for creation of a side-to-side jejuno-ileal anastomosis in adults with obesity and type 2 diabetes mellitus (T2DM).

Detailed description

The purpose of this clinical research study is to evaluate the feasibility/performance, safety and initial efficacy of the GT Metabolic Solutions DI Biofragmentable Magnetic Anastomosis System (Magnet System, DI Biofragmentable and hereafter referred to as the DI Magnet System) for creation of a side-to-side jejuno-ileal anastomosis in adults with obesity and type 2 diabetes mellitus (T2DM). This partial diversion of intestinal contents from jejunum to the ileum is intended to facilitate weight management/loss and improve metabolic outcomes. Side-by side anastomoses are currently created by sutures, staples, and anastomotic compression devices. This study explores a partial jejuno-ileal diversion procedure creating a side-to-side anastomosis with magnetic compression anastomosis.

Conditions

• Obesity
• Type 2 Diabetes

Interventions

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

Timeline

• Start date: 2024-02-13
• Primary completion: 2024-09-24
• Completion: 2025-06-24
• First posted: 2024-01-31
• Last updated: 2025-12-23

Locations

1 site across 1 country: Czechia