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Procedure

Magnetic Gastrointestinal Diversion for Obesity

N/A

Recruiting

Research Sponsored by GT Metabolic Solutions, Inc.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

If a child-bearing female, subject must commit to not becoming pregnant and agree to use contraception for the duration of the study

Agrees to refrain from any type of additional bariatric or reconstructive surgery that would affect body weight for the duration of the study

Timeline

Screening 3 weeks

Treatment Varies

Follow Up day 30

Awards & highlights

Study Summary

This trial tests a new tool to help obese adults with digestive issues.

Who is the study for?

Adults aged 18-65 with obesity (BMI 30-50) and Type 2 Diabetes (HbA1c ≥ 6.5%) or weight regain after sleeve gastrectomy are eligible for this trial. It's also open to those needing a gastro-jejunal diversion as part of gastric bypass surgery, without prior surgeries affecting the GI tract, uncontrolled diabetes, or other significant health issues.Check my eligibility

What is being tested?

The MagGJ System is being tested for its ability to create a connection between the stomach and intestines in obese adults to help with weight loss and diabetes management. The study will assess how feasible it is to use this system for gastro-ileal or gastro-jejunal diversion.See study design

What are the potential side effects?

Potential side effects may include discomfort at the site of magnet placement, risk of infection, bleeding from the procedure site, possible inflammation of internal organs where magnets are placed, and any typical risks associated with endoscopic or laparoscopic procedures.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I agree to use birth control and not get pregnant during the study.

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I agree not to have weight loss or reconstructive surgery during the study.

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I am between 18 and 65 years old.

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My BMI is between 30-50, and I have Type 2 Diabetes or have gained weight after sleeve gastrectomy.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ day 30

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~day 30

This trial's timeline: 3 weeks for screening, Varies for treatment, and day 30 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Anastomosis Patency

Magnet Placement

Natural Magnet Passage

Trial Design

1Treatment groups

Experimental Treatment

Group I: MagGJ SystemExperimental Treatment1 Intervention

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

0 / 4Eligibility criteria met

Find a Location

Who is running the clinical trial?

GT Metabolic Solutions, Inc.Lead Sponsor

3 Previous Clinical Trials

68 Total Patients Enrolled

3 Trials studying Obesity

68 Patients Enrolled for Obesity

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Might I be an appropriate candidate to join this trial?

"This medical trial is accessible to individuals between the ages of 18 and 65 who have obesity. There are 35 available spaces in total for this study."

Answered by AI

Is this medical experiment open to those under the age of 50?

"The eligibility criteria for this trial dictates that potential participants must be at least 18 years old and no older than 65."

Answered by AI

How extensive is the participant pool for this research endeavor?

"Affirmative. According to clinicaltrials.gov, this medical experiment is currently recruiting participants that meet the criteria set forth by researchers. The trial was initiated on October 31st 2023 and most recently refreshed on October 27th of 2023, with 35 patients being slated for enrollment at a single location."

Answered by AI

Are participants still needed for this research endeavor?

"Information hosted on clinicaltrials.gov reveals that recruiting for this medical trial is in progress and has been since October 31st 2023. The details of the study were recently updated on October 27th 2023."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

2023. "Magnetic Gastro-Ileal or Gastro-Jejunal Diversion Study ("MGI/MGJ Study")". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06073457.