Trials / Completed
CompletedNCT05692518
MagDI Diversion Feasibility Study
Creation of Side-to-Side Compression Anastomosis Using the GT Metabolic Solutions DI Bio-fragmentable Magnetic Anastomosis System to Achieve Duodeno-Ileostomy Diversion in Adults With Obesity and Type 2 Diabetes Mellitus
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 15 (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 of the GT Metabolic Solutions DI Bio-fragmentable Magnetic Anastomosis System (MAGNET System, DI Bio-fragmentable) for creation of a side-by-side anastomosis duodeno-ileostomy in obese adults.
Detailed description
The purpose of this clinical research study is to evaluate the feasibility of the GT Metabolic Solutions DI Bio-fragmentable Magnetic Anastomosis System (MAGNET System, DI Bio-fragmentable) for creation of a side-to-side anastomosis duodeno-ileostomy in obese adults. This partial diversion of intestinal contents from duodenum to the ileum is intended to facilitate weight management/loss in obese adults with type 2 diabetes mellitus (T2DM) 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 duodeno-ileostomy (SADI) procedure.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | MAGNET System, DI Bio-fragmentable | Anastomoses achieved by magnetic compression. |
Timeline
- Start date
- 2022-12-19
- Primary completion
- 2024-08-23
- Completion
- 2025-05-20
- First posted
- 2023-01-20
- Last updated
- 2025-12-23
Locations
1 site across 1 country: Georgia
Source: ClinicalTrials.gov record NCT05692518. Inclusion in this directory is not an endorsement.