Magnetic Gastrointestinal Diversion for Obesity

Recruiting at 2 trial locations

Overseen By Josh Schumacher

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: GT Metabolic Solutions, Inc.

Must not be taking: Injectable insulin, Anticoagulants

Disqualifiers: Type 1 diabetes, Uncontrolled T2DM, Uncontrolled hypertension, others

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

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 3

Duration: 1 day

35 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new treatment called the MagGJ System, a device designed to aid obesity by creating a special connection in the digestive system. The researchers aim to determine if this system can effectively support weight loss in individuals who have struggled with obesity, particularly those with Type 2 Diabetes or those who regained weight after sleeve gastrectomy. This trial may suit adults dealing with obesity and related conditions. Participants should be prepared to manage their weight without additional surgeries during the study. As an unphased trial, this study offers a unique opportunity to contribute to groundbreaking research in obesity treatment.

Will I have to stop taking my current medications?

The trial information does not specify if you need to stop taking your current medications. However, if you are on injectable insulin or require chronic anticoagulation therapy (except aspirin), you may not be eligible to participate.

What prior data suggests that the MagGJ System is safe for use in obese adults?

Research has shown that the MagGJ System, which connects parts of the intestines, has been tested in people. In an earlier study, patients handled the procedure well, and no serious safety issues arose. This system uses magnets to make the connection and is designed to break down naturally in the body.

Early results suggest that this method is generally safe for patients. However, like any treatment, minor side effects or discomfort might occur. It's important to note that this device is still being tested specifically for treating obesity. As research continues, more detailed safety information will become available. ^{1 2 3 4 5}

Why are researchers excited about this trial?

The MagGJ System is unique because it uses magnets to create a gastrointestinal diversion, offering a non-surgical approach to weight loss. Unlike standard obesity treatments like gastric bypass surgery, which physically alters the digestive system, the MagGJ System aims to reroute the digestive process without invasive procedures. Researchers are excited about this treatment because it could potentially reduce recovery time and lower the risk of complications associated with traditional bariatric surgeries.

What evidence suggests that the MagGJ System is effective for obesity?

Research shows that the MagGJ System, studied in this trial, uses magnets to create a new path in the digestive system and may aid weight loss in obese adults. In a previous study, patients who underwent a similar magnetic procedure saw their HbA1c levels—a measure of blood sugar control—drop from 6% to 5.5% over 90 days. This suggests potential benefits for both weight loss and diabetes management. The procedure is minimally invasive, involving less surgery. Early results are promising, but further research is needed to confirm its long-term effectiveness and safety. ^{1 2 3 6 7}

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

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

My BMI is between 35 and 50, and I haven't had a sleeve gastrectomy.

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

Exclusion Criteria

I am currently pregnant or breastfeeding.

I am scheduled for an MRI within two months after the study procedure.

Recent tobacco or nicotine product cessation; cessation ≤ 3 months prior to informed consent

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Placement of the MagGJ System to create a side-to-side anastomosis for gastro-ileal or gastro-jejunal diversion

1 day

1 visit (in-person)

Follow-up

Participants are monitored for anastomosis patency and natural magnet passage

30 days

2 visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• MagGJ System

Trial Overview 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.

How Is the Trial Designed?

Group I: MagGJ System Experimental Treatment 1 Intervention

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

MagGJ System is already approved in United States for the following indications:

Approved in United States as MagGJ System for:

• Obesity

Who Is Running the Clinical Trial?

GT Metabolic Solutions, Inc.

Lead Sponsor

Trials

8

Recruited

290+

Published Research Related to This Trial

The study successfully developed a linear magnet device that created a patent duodeno-ileal anastomosis in a porcine model, demonstrating its potential for minimally invasive metabolic/bariatric surgery.

In the verification phase, the device resulted in well-vascularized anastomoses with minimal inflammation, indicating its efficacy and safety for future human applications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Side-to-side duodeno-ileal magnetic compression anastomosis: design and feasibility of a novel device in a porcine model. Gagner, M., Krinke, T., Lapointe-Gagner, M., et al.[2023]

The Magnet System (MS) for creating a side-to-side duodeno-ileostomy showed promising safety and effectiveness in a study of 24 patients, with no device-related adverse events and only three serious procedure-related complications.

Patients experienced significant weight loss (average of 28.1% at 6 months) and improvements in type 2 diabetes markers, with notable reductions in HbA1C and glucose levels, indicating the potential of this novel approach for obesity and diabetes management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Side-to-side magnet anastomosis system duodeno-ileostomy with sleeve gastrectomy: early multi-center results. Gagner, M., Cadiere, GB., Sanchez-Pernaute, A., et al.[2023]

The Implantable Gastric Stimulator (IGS) is a new bariatric procedure that promotes feelings of fullness without altering the stomach's anatomy, making it a safer alternative to traditional weight-loss surgeries.

IGS therapy is designed to work alongside diet and lifestyle changes, and it offers advantages such as a simpler, quicker procedure with fewer nutritional side effects compared to other bariatric options.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Bariatric pacing. A new frontier for the treatment of severe obesity]. Gaggiotti, G., Di Matteo, F., Sirolla, C.[2006]

Intragastric balloons (IGBs) can lead to an average weight loss of about 5.5-5.6% over 6 months, which is less effective than bariatric surgery and some weight loss medications, indicating limited efficacy for obesity treatment.

The use of IGBs is associated with a 10.5% incidence of serious adverse events, including new complications like acute pancreatitis, raising concerns about their safety and long-term viability as a treatment option.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Intragastric Balloon Treatment for Obesity: Review of Recent Studies. Tate, CM., Geliebter, A.[2018]

The Levita™ Magnetic Surgical System, used in laparoscopic cholecystectomy, was found to be safe and effective, with no perioperative complications reported in a study of 10 patients.

Surgeons noted that the magnetic grasper was user-friendly and provided good tissue retraction, suggesting that this system could reduce the number of laparoscopic trocars needed, potentially leading to less tissue damage and better cosmetic outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Magnetic surgery: first U.S. experience with a novel device. Haskins, IN., Strong, AT., Allemang, MT., et al.[2019]

The Incisionless Anastomosis System (IAS) successfully created leak-free intestinal bypasses in 100% of the Yorkshire pigs studied, demonstrating its efficacy and safety in a minimally invasive setting.

The procedure was quick, averaging 14.7 minutes, and resulted in fully patent anastomoses with no complications such as adhesions or inflammation, indicating strong long-term integrity of the bypass.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Endoscopic intestinal bypass creation by using self-assembling magnets in a porcine model. Ryou, M., Agoston, AT., Thompson, CC.[2016]

Gastric electrical stimulation (GES) has shown promising results in achieving weight loss, particularly within the first 12 months, based on a systematic review of 31 studies involving 33 trials.

While many studies reported positive outcomes, including changes in appetite and metabolic markers, there is a need for more standardized and long-term research to fully understand the effectiveness and safety of GES for obesity treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Updates on gastric electrical stimulation to treat obesity: Systematic review and future perspectives. Cha, R., Marescaux, J., Diana, M.[2021]

A novel magnetic compression technique for gastrojejunostomy was successfully tested in rabbits, demonstrating that both cylindrical and rectangular magnets could establish the procedure effectively, with all animals undergoing successful surgeries.

The magnets entered the jejunum within a few days and created stable anastomoses with similar burst pressures, indicating that this method could simplify bariatric surgery in humans while maintaining safety and efficacy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Further Development of Magnetic Compression for Gastrojejunostomy in Rabbits. Qiao, W., Shi, A., Ma, F., et al.[2020]

In a study of 224 patients with morbid obesity who underwent adjustable gastric band surgery, the total complication rate was 19%, but there were no deaths, indicating that while the procedure has risks, it is generally safe when performed by experienced surgeons.

The average excess weight loss after 2 years was 50% of the excess weight, but this outcome was influenced by patient compliance and careful selection of candidates for the surgery, suggesting that better patient management could enhance results.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Success and failure in laparoscopic "gastric banding". A report of 3 years experience]. Kunath, U., Susewind, M., Klein, S., et al.[2019]

Implantable Gastric Stimulation (IGS) is a promising new method for weight loss that uses a pacemaker-like device to electrically stimulate the stomach, showing safety in over 500 patients worldwide.

The procedure is minimally invasive and has been associated with improving weight loss results as patient selection and device application are refined, suggesting it could become a reliable option for obesity treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Implantable gastric stimulation for the treatment of severe obesity. Shikora, SA.[2014]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06073457

Magnetic Gastro-Ileal or Gastro-Jejunal Diversion Study ("MGI/ ... The purpose of this clinical research study is to evaluate the feasibility of the GT Metabolic Solutions Magnet System, GJ Biofragmentable ("MagGJ System") ...

2. sciencedirect.com sciencedirect.com/science/article/pii/S1091255X2500126X

First-in-human side-to-side linear magnetic compression ... Endpoints and outcome metrics. The primary MagGI procedure endpoint was feasibility at 30 days confirmed by (i) surgical placement and alignment of the MagGI ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12262126/

First-in-Human Side-to-Side Duodenoileal Bipartition for ... The biofragmentable magnetic anastomosis system (BMAS) is endolaparoscopically placed to effect magnetic duodenoileostomy (MagDI) bipartition ...

4. withpower.com withpower.com/trial/phase-obesity-9-2023-44a3d

Magnetic Gastrointestinal Diversion for Obesity The purpose of this clinical research study is to evaluate the feasibility of the GT Metabolic Solutions Magnet System, GJ Biofragmentable ("MagGJ System") ...

5. sciety.org sciety.org/articles/activity/10.21203/rs.3.rs-7519191/v1?utm_source=sciety_labs_article_page

Creation of Side-to-Side Compression Anastomosis Using the ... Mean HbA1c decreased from 6% at baseline to 5.7% at 30 days and to 5.5% at 90 days. Conclusion Preliminary data shows that side-to-side magnet ...

6. ifso.com ifso.com/pdf/michel-gagner-new-updated.pdf

MAGNETIC SURGERY will have a significant place for ... The secondary outcomes of weight loss and functional improvement in metabolic indicators are promising in this cohort at 6-12 months. Page 30. The MAGGI ( ...

7. ctv.veeva.com ctv.veeva.com/study/creation-of-side-to-side-compression-anastomosis-using-the-gt-metabolic-solutions-di-biofragmentable

Creation of Side-to-Side Compression Anastomosis Using the ... The purpose of this clinical research study is to evaluate the feasibility / performance, safety and initial efficacy of the GT Metabolic ...