Trials / Active Not Recruiting
Active Not RecruitingNCT07085741
Creation of Side-to-Side Compression Anastomosis Using the GT Metabolic Solutions DI Biofragmentable Magnetic Anastomosis System in Mexico
Creation of Side-to-Side Compression Anastomosis Using the GT Metabolic Solutions DI Biofragmentable Magnetic Anastomosis System (MAGNET System, DI Biofragmentable) to Achieve Duodeno-Ileostomy Diversion in Adults With Obesity and Type 2 Diabetes Mellitus: MAGNET 2 Study
- Status
- Active Not Recruiting
- 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 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) for creation of a side-to-side anastomosis duodeno-ileostomy in obese adults.
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) 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 Biofragmentable | Anastomoses achieved by magnetic compression. |
Timeline
- Start date
- 2025-05-07
- Primary completion
- 2025-10-19
- Completion
- 2026-07-16
- First posted
- 2025-07-25
- Last updated
- 2025-12-23
Locations
1 site across 1 country: Mexico
Source: ClinicalTrials.gov record NCT07085741. Inclusion in this directory is not an endorsement.