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

NCT07085741 | Active Not Recruiting

• 1 other identifier: GTM-002
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Obesity; Type 2 Diabetes

Outcome Measures

Primary Outcomes (3)

• Magnet Placement

  MagGJ System placement ≥ 90% alignment of magnets

  1 Day (during study index procedure)

• Natural Magnet Passage

  Passage of magnets without surgical re-intervention

  Index Procedure through 90 days

• Anastomosis Patency

  Confirmed radiologically

  Index Procedure through 90 days

Study Arms (1)

MAGNET System, DI Biofragmentable

EXPERIMENTAL

GT Metabolic Solutions DI Biofragmentable Magnetic Anastomosis System (MAGNET System, DI Biofragmentable)

Device: MAGNET System, DI Biofragmentable

Interventions

MAGNET System, DI Biofragmentable DEVICE

Anastomoses achieved by magnetic compression.

MAGNET System, DI Biofragmentable

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Type 1 diabetes
• Use of injectable insulin
• Uncontrolled T2DM
• Previous sleeve gastrectomy procedure or plan to perform a sleeve gastrectomy with the duodeno-ileal anastomosis procedure
• Uncontrolled hypertension, dyslipidemia or sleep apnea
• Prior intestinal, colonic or duodenal surgery, other than bariatric
• Prior surgery, trauma, prostheses, disease or genetic expression which prevent or contra-indicate the procedure, including scarring and abnormal anatomy.
• Refractory gastro-esophageal reflux disease (GERD)
• Barrett's disease
• Helicobacter pylori positive and/or active ulcer disease
• Large hiatal hernia
• Inflammatory bowel or colonic diverticulitis disease
• Any anomaly precluding orogastric access by gastroscope and catheters, and manipulation techniques.
• Implantable pacemaker or defibrillator
• Psychiatric disorder, except well-controlled depression with medication for \>6 months

Sponsors & Collaborators

• GT Metabolic Solutions, Inc.: lead

Study Sites (1)

Corporativo Hospital Satelite

Naucalpan, Mexico

Location

MeSH Terms

Conditions

Obesity; Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: This is an open-label, multicenter study enrolling up to 25 subjects at up to 3 study centers in Mexico

Study Record Dates

• First Submitted: April 8, 2025
• First Posted: July 25, 2025
• Study Start: May 7, 2025
• Primary Completion: October 19, 2025
• Study Completion (Estimated): July 16, 2026
• Last Updated: December 23, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

ME (1)