RecruitingNot ApplicableNCT06073457

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


Sponsor

GT Metabolic Solutions, Inc.

Enrollment

35 participants

Start Date

Nov 6, 2023

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 YearsMax Age: 65 Years

Plain Language Summary

Simplified for easier understanding

This study tests a magnetic device that creates a bypass between the stomach and a part of the small intestine to treat obesity and type 2 diabetes. The device is placed endoscopically (through the mouth) without major open surgery. Researchers want to see if it is safe and effective as a weight loss treatment or as a first stage of a larger procedure. **You may be eligible if...** - You are between 18 and 65 years old - You have a BMI between 30–50 AND have type 2 diabetes (HbA1c ≥ 6.5%), OR - You had prior sleeve gastrectomy with weight regain, OR - You have a BMI of 35–50 and are a candidate for a two-stage gastric bypass procedure - You agree to dietary and lifestyle guidelines post-procedure **You may NOT be eligible if...** - You have had certain prior stomach or intestinal surgeries that are incompatible with this device - You have severe eating disorders, uncontrolled substance use, or serious psychiatric conditions - You are pregnant or planning pregnancy within the study timeframe - You have allergies to nickel or titanium (the device materials) Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICEMagGJ System

Anastomoses achieved by magnetic compression.


Locations(4)

Westmount Surgical Center

Westmount, Quebec, Canada

Clinica MEDS La Dehesa SpA

Santiago, Chile

Hospital Lusiadas Amadora

Amadora, Portugal

Cleveland Clinic Abu Dhabi

Abu Dhabi, United Arab Emirates

View Full Details on ClinicalTrials.gov

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NCT06073457


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