NCT06073457

Magnetic Gastro-Ileal or Gastro-Jejunal Diversion Study ("MGI/MGJ Study")

Creation of Side-to-Side Compression Anastomosis Using the GT Metabolic Solutions Magnet System, GJ Biofragmentable to Achieve Gastro-Ileal or Gastro-Jejunal Diversion in Adults With Obesity

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 35 (estimated)
• 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 of the GT Metabolic Solutions Magnet System, GJ Biofragmentable ("MagGJ System") for creation of a side-to-side anastomosis for gastro-ileal or gastro-jejunal diversion in obese adults.

Detailed description

The purpose of this clinical research study is to evaluate the feasibility of the GT Metabolic Solutions Magnet System, GJ Biofragmentable ("MagGJ System") for creation of a side-to-side anastomosis for gastro-ileal or gastro-jejunal diversion in obese adults. This partial diversion of intestinal contents from the stomach to the ileum or jejunum is intended to facilitate weight management/loss in obese adults and improve metabolic outcomes in obese adults with type 2 diabetes mellitus ("T2DM"). Side-by-side anastomoses are currently created by sutures, staples, and anastomotic compression devices. A predicate procedure is the single anastomosis sleeve ileal (SASI) bypass procedure that includes a gastro-ileostomy at the distal antrum of the stomach. Additionally, the one anastomosis gastric bypass (OAGB) or single anastomosis gastric bypass (SAGB) performed in two stages may also be considered a predicate procedure where an anastomosis between the jejunum and anterior lesser curvature of the stomach is performed, followed by a second stage gastric pouch stapling more than 12 months later (non-study procedure).

Conditions

• Obesity
• Type 2 Diabetes

Interventions

Type	Name	Description
DEVICE	MagGJ System	Anastomoses achieved by magnetic compression.

Timeline

• Start date: 2023-11-06
• Primary completion: 2026-03-01
• Completion: 2027-01-01
• First posted: 2023-10-10
• Last updated: 2025-12-23

Locations

4 sites across 4 countries: Canada, Chile, Portugal, United Arab Emirates