Actively Recruiting
Magnetic Gastro-Ileal or Gastro-Jejunal Diversion Study ("MGI/MGJ Study")
Led by GT Metabolic Solutions, Inc. · Updated on 2025-12-23
35
Participants Needed
4
Research Sites
164 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
Magnetic Gastro-Ileal or Gastro-Jejunal Diversion Study ("MGI/MGJ Study")
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 18 to 65 years of age at the time of informed consent
- Body mass index (BMI) between 30 and 50 kg/m2 with either type 2 diabetes mellitus (HbA1c ≥ 6.5%) or weight regain after sleeve gastrectomy more than 12 months ago and indicated for gastro-ileal diversion
- BMI between 35 and 50 kg/m2 without previous sleeve gastrectomy and indication for gastro-jejunal diversion as first stage of a two-stage one anastomosis gastric bypass (OAGB) or single anastomosis gastric bypass (SAGB) with second stage gastric pouch stapling more than 12 months later (non-study procedure)
- Agreement to avoid additional bariatric or reconstructive surgery affecting body weight during the study
- Female participants of childbearing potential must agree to use contraception and not become pregnant during the study
- Willingness and ability to comply with study protocol requirements
You will not qualify if you...
- Type 1 diabetes
- Use of injectable insulin
- Uncontrolled type 2 diabetes mellitus
- Planned sleeve gastrectomy, hiatal hernia repair, or cholecystectomy with the investigational gastro-ileal anastomosis procedure
- Uncontrolled hypertension, dyslipidemia, or sleep apnea
- Prior intestinal, colonic, or duodenal surgery other than bariatric surgery
- Conditions preventing or contraindicating the procedure such as scarring, abnormal anatomy, or genetic factors
- Refractory gastro-esophageal reflux disease (GERD) or Barrett's disease
- Helicobacter pylori infection or active ulcer disease
- Large hiatal hernia
- Inflammatory bowel disease or colonic diverticulitis
- Any anomaly preventing orogastric access by gastroscope and catheters
- Implantable pacemaker or defibrillator
- Psychiatric disorder except well-controlled depression with medication for more than 6 months
- History of substance abuse
- Pregnancy or breastfeeding
- Not agreeing to use effective contraception if of childbearing potential
- Medical conditions or comorbidities making subject medically unfit or unsafe for the procedure
- Unhealed ulcers, bleeding lesions, tumors, or lesions at magnet deployment site
- Expected MRI within two months after procedure
- Any anomaly preventing endoscopic or laparoscopic access
- Surgery or intervention within 30 days before study procedure
- Scheduled surgery or intervention within 30 days after study procedure
- Stroke or transient ischemic attack within 6 months before consent
- Requires chronic anticoagulation therapy except aspirin
- Active infections requiring antibiotics unless resolved before procedure
- Unable to comply with follow-up visits and assessments
- Recent tobacco or nicotine product cessation within 3 months prior to consent
- Known allergies to device components or contrast media
- Limited life expectancy due to terminal disease
- Currently participating in another clinical research study with investigational drug or device
- Positive COVID-19 test prior to procedure if required by local protocols
- Any condition that may prevent completing follow-up through day 360 or interfere with study results
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 4 locations
1
Westmount Surgical Center
Westmount, Quebec, Canada, H3Z 2P9
Actively Recruiting
2
Clinica MEDS La Dehesa SpA
Santiago, Chile
Actively Recruiting
3
Hospital Lusiadas Amadora
Amadora, Portugal
Actively Recruiting
4
Cleveland Clinic Abu Dhabi
Abu Dhabi, United Arab Emirates
Actively Recruiting
Research Team
L
Lisa Griffin Vincent, PhD
CONTACT
J
Josh Schumacher
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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