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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

NCT07085741•GT Metabolic Solutions, Inc.

View on ClinicalTrials.gov

Summary

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.

Eligibility

Age

18 - 65 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. 18-65 years of age, inclusive, at the time of informed consent
•2. BMI 30-34.9 kg/m2
•3. Type 2 Diabetes Mellitus (T2DM; defined as HbA1c 6.5%), without previous sleeve gastrectomy, and without plan to perform a concurrent sleeve gastrectomy.
•4. Agrees to refrain from any type of additional bariatric or reconstructive surgery that would affect body weight for the duration of the study
•5. If a child-bearing female, subject must commit to not becoming pregnant and agree to use contraception for the duration of the study
•6. Willing and able to comply with protocol requirements

Exclusion Criteria

•1. Type 1 diabetes
•2. Use of injectable insulin
•3. Uncontrolled T2DM
•4. Previous sleeve gastrectomy procedure or plan to perform a sleeve gastrectomy with the duodeno-ileal anastomosis procedure
•5. Uncontrolled hypertension, dyslipidemia or sleep apnea
•6. Prior intestinal, colonic or duodenal surgery, other than bariatric
•7. Prior surgery, trauma, prostheses, disease or genetic expression which prevent or contra-indicate the procedure, including scarring and abnormal anatomy.
•8. Refractory gastro-esophageal reflux disease (GERD)
•9. Barrett's disease
•10. Helicobacter pylori positive and/or active ulcer disease
+24 more criteria

Locations (1)

Corporativo Hospital Satelite

Naucalpan, Mexico

Key Dates

Start Date

May 7, 2025

Primary Completion Date

October 19, 2025

Completion Date

July 16, 2026

Last Updated

December 23, 2025

Enrollment

ACTUAL participants

Conditions

ObesityType 2 Diabetes

Interventions

MAGNET System, DI Biofragmentable

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: December 23, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

Creation of Side-to-Side Compression Anastomosis Using the GT Metabolic Solutions DI Biofragmentable Magnetic Anastomosis System in Mexico

Inclusion Criteria

Exclusion Criteria

Multi-Acupoint Laser Therapy for Body Shape and Composition in Obese Menopausal Women

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