Magnetic Gastrointestinal Diversion for Obesity

Recruiting at 1 trial location

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

Trial Summary

What is the purpose of this trial?

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.

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 data supports the effectiveness of the MagGJ System treatment for obesity?

Research on similar treatments like Implantable Gastric Stimulation (IGS) shows that using devices to stimulate the stomach can lead to weight loss and is generally safe. These treatments are less invasive than traditional surgery and have been improving in effectiveness with better patient selection and application. ^{1 2 3 4 5}

How is the MagGJ System treatment for obesity different from other treatments?

The MagGJ System is unique because it uses magnetic compression to create a connection between parts of the digestive system, which is a less invasive method compared to traditional surgery that uses sutures or staples. This approach aims to reduce complications like bleeding and leaks, making it a novel option for weight loss and metabolic improvements. ^{6 7 8 9 10}

Eligibility Criteria

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

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)

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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 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]

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]

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]

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 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 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]

References

1. United States pubmed.ncbi.nlm.nih.gov

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

2. United States pubmed.ncbi.nlm.nih.gov

Intragastric Balloon Treatment for Obesity: Review of Recent Studies. [2018]

3. Italy pubmed.ncbi.nlm.nih.gov

[Bariatric pacing. A new frontier for the treatment of severe obesity]. [2006]

4. Germany pubmed.ncbi.nlm.nih.gov

[Success and failure in laparoscopic "gastric banding". A report of 3 years experience]. [2019]

5. United States pubmed.ncbi.nlm.nih.gov

Updates on gastric electrical stimulation to treat obesity: Systematic review and future perspectives. [2021]

6. United States pubmed.ncbi.nlm.nih.gov

Further Development of Magnetic Compression for Gastrojejunostomy in Rabbits. [2020]

7. Germany pubmed.ncbi.nlm.nih.gov

Side-to-side magnet anastomosis system duodeno-ileostomy with sleeve gastrectomy: early multi-center results. [2023]

8. Germany pubmed.ncbi.nlm.nih.gov

Side-to-side duodeno-ileal magnetic compression anastomosis: design and feasibility of a novel device in a porcine model. [2023]

9. Germany pubmed.ncbi.nlm.nih.gov

Magnetic surgery: first U.S. experience with a novel device. [2019]

10. United States pubmed.ncbi.nlm.nih.gov

Endoscopic intestinal bypass creation by using self-assembling magnets in a porcine model. [2016]