Active — Not RecruitingNot Applicable

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

Canada, Chile, Portugal35 participantsStarted 2023-11-06

Plain-language 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.

Who can participate

Age range

18 Years – 65 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * 18-65 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 Exclusion Criteria: * 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 t…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1This trial is testing magnets placed inside the digestive tract to create a bypass connection — can you explain how the magnets are placed and removed, and what happens if they don't pass naturally on their own?
2Since this study is in a phase labeled 'NA' and is measuring very basic things like whether the magnets stay in place and whether the new connection remains open, does that mean it's still very early-stage research where not much is known yet about long-term safety?
3The trial is listed as 'active but not recruiting' — does that mean enrollment is closed, and if so, are there similar or follow-up studies you'd recommend I look into instead?
4Given that this approach involves creating a physical bypass between the stomach and small intestine using magnets, how does the risk profile compare to established surgical options like gastric bypass or sleeve gastrectomy that I might consider?
5If I have both obesity and Type 2 diabetes, would you recommend I try standard treatments or already-approved procedures first before considering an experimental approach like this one?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Magnet Placement

Timeframe: 1 Day

Natural Magnet Passage

Timeframe: 30 Days

Anastomosis Patency

Timeframe: Day 30

Trial details

NCT IDNCT06073457

SponsorGT Metabolic Solutions, Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2026-04-17

View on ClinicalTrials.gov More Obesity trials

Who can participate

Age range

18 Years – 65 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.