Magnetic Gastro-Ileal or Gastro-Jejunal Diversion Study ("MGI/MGJ Study")

NCT06073457 | Active Not Recruiting DMC

• 1 other identifier: GTM-003
• Study Type: interventional
• Target: 35
• Locations: 4 countries
• Sites: 4

Brief 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.

Conditions

Obesity; Type 2 Diabetes

Outcome Measures

Primary Outcomes (3)

• Magnet Placement

  MagGJ System placement ≥ 90% alignment of magnets

  1 Day

• Natural Magnet Passage

  Passage of magnets without surgical re-intervention

  30 Days

• Anastomosis Patency

  Confirmed radiologically or fluoroscopically

  Day 30

Study Arms (1)

MagGJ System

EXPERIMENTAL

GT Metabolic Solutions Magnet System, GJ Biofragmentable ("MagGJ System")

Device: MagGJ System

Interventions

MagGJ System DEVICE

Anastomoses achieved by magnetic compression.

MagGJ System

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 30-50 kg/m2, inclusive with either (A) Type 2 Diabetes Mellitus (T2DM), defined as HbA1c ≥ 6.5%, or (B) Weight regain following previous sleeve gastrectomy (\>12 months) and indicated for a gastro-ileal diversion; OR
• BMI 35-50 kg/m2, inclusive without previous sleeve gastrectomy, and where (A) Gastro-jejunal diversion is indicated for the first stage, of a 2-stage, one anastomosis gastric bypass (OAGB), or (B) Single anastomosis gastric bypass (SAGB), with the second stage gastric pouch stapling performed \>12 months after the gastro-ileal diversion, and not part of the investigational study
• 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
• Plan to perform a sleeve gastrectomy and/or hiatal hernia repair and/or cholecystectomy with the investigational study gastro-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 (4)

Westmount Surgical Center

Westmount, Quebec, H3Z 2P9, Canada

Location

Clinica MEDS La Dehesa SpA

Santiago, Chile

Location

Hospital Lusiadas Amadora

Amadora, Portugal

Location

Cleveland Clinic Abu Dhabi

Abu Dhabi, United Arab Emirates

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: A 2-stage, open-label, multicenter study enrolling up to 35 subjects at 6 study centers, as follows: * Stage 1: First-in-human (FIH) and proof-of-concept with up to 5 subjects; and * Stage 2: Feasibility with up to 30 subjects There will be a pause after completing enrollment in Stage 1 to allow completion of Day 30 and evaluation of safety by the independent Data Safety Monitoring Committee (DSMB). The DSMB will confirm whether the study can advance to Stage 2. All subjects in Stage 1 and 2 will be followed for 12 months.

Study Record Dates

• First Submitted: July 17, 2023
• First Posted: October 10, 2023
• Study Start: November 6, 2023
• Primary Completion: April 17, 2026
• Study Completion (Estimated): January 1, 2027
• Last Updated: May 20, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

CL (1); PT (1); CA (1); AE (1)