Magnet System for Gastrointestinal Disorders

Overseen By Josh Schumacher

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: GT Metabolic Solutions, Inc.

Disqualifiers: Concurrent surgeries, Pacemaker, Malignancy, Pregnancy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 1 day

35 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new device called the GT Metabolic Magnet System to treat certain stomach and bowel issues. The goal is to evaluate how effectively this device creates a connection between parts of the stomach or small bowel, necessary for some surgeries. Suitable candidates may have conditions such as superior mesenteric artery syndrome (a blockage near the intestines), gastric outlet obstruction (a blockage at the stomach's end), or partial small bowel obstruction (a blockage in the small intestine). Participants should not require immediate open pathways in their digestive tract post-surgery. As an unphased trial, this study offers a unique opportunity to contribute to groundbreaking research that could enhance future surgical outcomes.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial team or your doctor.

What prior data suggests that the GT Metabolic Magnet System is safe for gastrointestinal procedures?

Research shows that the GT Metabolic Magnet System connects parts of the stomach or small intestine. This connection, called an anastomosis, is often necessary in certain medical treatments. Studies have found that using magnets for this purpose can be effective and safe.

One study examined patient responses to this system and found that adults generally tolerated the procedure well. Although any medical procedure carries risks, research so far suggests that the GT Metabolic Magnet System is a relatively safe option for those needing this type of surgery.

Prospective trial participants should discuss any concerns with their doctor, who can help explain how this treatment might work for them. ^{1 2 3 4 5}

Why are researchers excited about this trial?

The GT Metabolic Magnet System is unique because it offers a non-invasive approach to treating gastrointestinal disorders. Unlike traditional treatments that often rely on medications or surgery, this system uses magnetic fields to potentially influence metabolic processes in the gut. Researchers are excited about this method because it could provide a novel way to manage symptoms without the side effects typically associated with drugs, offering a new hope for patients looking for alternative treatments.

What evidence suggests that the GT Metabolic Magnet System is effective for gastrointestinal disorders?

Research shows that the GT Metabolic Magnet System, which participants in this trial will receive, can aid in weight loss and enhance metabolic health. In earlier studies, participants lost about 34% of their total weight after 12 months. They also shed around 80% of their excess weight and experienced a significant decrease in Body Mass Index (BMI). Additionally, the system reduced HbA1C levels, a measure of blood sugar control, from 6.8%. This suggests that the system may help manage weight and improve health issues related to being overweight. ^{1 2 3 6 7}

Are You a Good Fit for This Trial?

This trial is for adults with certain gastrointestinal disorders like gastric outlet obstruction or superior mesenteric artery syndrome. Specific eligibility criteria are not provided, but typically participants would need to meet certain health standards and have a condition that requires anastomosis treatment.

Inclusion Criteria

I am cleared for surgery according to my hospital's rules.

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

I need surgery for my stomach or small intestine due to a blockage.

Exclusion Criteria

Expected need for Magnetic Resonance Imaging (MRI) within the first 3 months post-procedure (or before if Magnet expulsion is confirmed radiologically)

Known allergies to the device components (including the biofragmentable material PGLA or similar compounds) or contrast media

I don't have any conditions that would prevent the use of scopes or tubes in my stomach.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo the placement and connection of two intraluminal magnets using the GT Metabolic Magnet System

1 day

Follow-up

Participants are monitored for safety and effectiveness, including the successful passage of magnets and anastomosis patency

90 days

What Are the Treatments Tested in This Trial?

Interventions

• GT Metabolic Magnet System

Trial Overview

The GT Metabolic Magnet System is being tested in this study. It's a device used to create a connection between two parts of the stomach or small bowel (anastomosis) without surgery, which may be needed for some gastrointestinal conditions.

How Is the Trial Designed?

Group I: Magnet System Experimental Treatment 1 Intervention

GT Metabolic Magnet System comprised of GT Metabolic Magnet System ("Magnet System")

Who Is Running the Clinical Trial?

GT Metabolic Solutions, Inc.

Lead Sponsor

Trials

8

Recruited

290+

Citations

1.

clinicaltrials.gov

clinicaltrials.gov/study/NCT07317076

NCT07317076 | GT Metabolic Magnet System in Adults ...

Evaluate the performance and safety of the GT Metabolic Magnet System for the creation of side-to-side compression anastomosis in the stomach ...

2.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC10345004/

First-in-Human Side-to-Side Magnetic Compression Duodeno ...

Total weight loss at 12 months was 34.0 ± 1.4% (SEM); excess weight loss, 80.2 ± 6.6%; and BMI reduction, 15.1. Mean HbA1C (%) dropped from 6.8 ...

3.

gtmetabolic.com

gtmetabolic.com/education/

Education

Evolution of Magnetic Gastrointestinal Compression Anastomosis. * Preclinical studies. Historical Gastrointestinal Compression Anastomosis. Non ...

4.

accessdata.fda.gov

accessdata.fda.gov/cdrh_docs/pdf24/DEN240013.pdf

July 2, 2024 GT Metabolic Solutions, Inc. Lisa Griffin Vincent ...

The GT Metabolic MagDI™ System is intended for use in the creation of side-to-side duodeno-ileal anastomoses in minimally invasive and ...

5.

sciencedirect.com

sciencedirect.com/science/article/pii/S1091255X2500126X

First-in-human side-to-side linear magnetic compression ...

Revisional SASI is effective. It can arrest weight regain, reinitiate significant weight loss, and improve post-SG metabolic deficiencies [24], [35] ...

6.

accessdata.fda.gov

accessdata.fda.gov/cdrh_docs/reviews/DEN240013.pdf

Magnetic compression anastomosis system. A magnetic ...

The GT Metabolic MagDI System is intended for use in the creation of side-to-side duodeno-ileal anastomoses in minimally invasive and ...

7.

ctv.veeva.com

ctv.veeva.com/study/gt-metabolic-magnet-system-in-adults-with-gastrointestinal-disorders

GT Metabolic Magnet System in Adults With Gastrointestinal ...

Evaluate the performance and safety of the Magnet System as a surgical tool for anastomosis in participants who have partial small bowel ...