MagDI System for Intestinal Surgery

Recruiting at 2 trial locations

Overseen By Lisa Griffin Vincent, PhD

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, others

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

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 1

Duration: Immediate (procedure day)

60 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new device, the MagDI System (Magnetic Compression Anastomosis System), to evaluate its effectiveness and safety for individuals requiring a specific type of intestinal surgery. The procedure focuses on partial intestinal diversion, which can benefit those with Type 2 Diabetes or weight regain after certain surgeries. Suitable candidates include individuals with Type 2 Diabetes and a Body Mass Index (BMI) between 30 and 50, or those who have regained weight after surgeries like sleeve gastrectomy. As an unphased trial, this study provides a unique opportunity to contribute to innovative research that could enhance future treatment options.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, you cannot participate if you use injectable insulin or require chronic anticoagulation therapy (except aspirin).

What prior data suggests that the MagDI System is safe for intestinal surgery?

Research has shown that the MagDI System, which uses magnets to connect parts of the intestine, has been safe in earlier studies. These studies found that the procedure could be completed successfully without major safety issues immediately afterward.

Similar magnetic systems have succeeded in over 87% of cases. Some problems, such as the new connections between intestines not holding or scarring, were noted but were uncommon.

In one study with the MagDI System, 64 unwanted effects were reported. Most occurred in individuals who underwent multiple surgeries simultaneously, suggesting that combining surgeries might increase risks.

Overall, the MagDI System has generally been well-tolerated, but like all medical procedures, it carries a chance of complications. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the MagDI System for intestinal surgery because it offers a unique approach compared to traditional surgical options. Unlike conventional methods that rely on sutures or staples, the MagDI System uses a biofragmentable magnet system. This innovative method aims to provide a less invasive solution, which could potentially reduce recovery time and minimize complications. By offering a new mechanism for tissue approximation, the MagDI System stands out as a promising advancement in surgical technology.

What evidence suggests that the MagDI System is effective for intestinal surgery?

Research has shown that the MagDI System, used in this trial, employs magnets to connect parts of the intestine. This method is less invasive, involving smaller cuts, which results in less pain and quicker recovery. Studies have found that this technique can successfully connect the intestines without leaving a permanent device inside the body. Early findings suggest this method might be safer and easier for patients, as it avoids some common problems of traditional surgery. Although more research is needed, the initial results are promising for those requiring intestinal surgery. ^{1 2 6 7 8}

Are You a Good Fit for This Trial?

The MagDI Canada Study is for individuals with obesity and Type 2 Diabetes who require a specific surgical procedure called duodeno-ileal side-to-side anastomosis. The study seeks participants who are suitable candidates for this intestinal surgery.

Inclusion Criteria

Body Mass Index (BMI) between 30-50 kg/m2

Participant has been informed of the nature of the study and agrees to its provisions, complying with study required testing, medications, follow-up visits, and has provided written informed consent

I have Type 2 Diabetes or have gained weight after stomach surgery.

Exclusion Criteria

I have not had a stroke or TIA in the last 6 months.

Participants with comorbidities that are likely to result in a life expectancy of 12 months

I am on long-term blood thinner medication (not including aspirin).

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo the duodeno-ileal diversion procedure using the MagDI System

Immediate (procedure day)

1 visit (in-person)

Initial Follow-up

Participants are monitored for performance of the anastomosis and safety of the MagDI System

90 days

Multiple visits (in-person and virtual)

Extended Follow-up

Participants are monitored for long-term safety outcomes related to the MagDI System

360 days

What Are the Treatments Tested in This Trial?

Interventions

• MagDI System

Trial Overview This trial tests the MagDI System, which is used during the duodeno-ileal side-to-side anastomosis procedure. It aims to assess how well it works and its safety, along with initial effectiveness in rerouting part of the small intestine.

How Is the Trial Designed?

Group I: Magnet System, DI Biofragmentable Experimental Treatment 1 Intervention

GT Metabolic Solutions Magnet System, DI Biofragmentable (MagDI System)

MagDI System is already approved in United States, Canada for the following indications:

Approved in United States as MagDI System for:

• Side-to-side duodeno-ileal anastomosis

Approved in Canada as MagDI System for:

• Duodeno-ileal (small bowel) side-to-side anastomosis procedure for partial intestinal diversion

Who Is Running the Clinical Trial?

GT Metabolic Solutions, Inc.

Lead Sponsor

Trials

8

Recruited

290+

Published Research Related to This Trial

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]

In a study involving 41 patients with obstructive jaundice, magnetic compression bilioenteric anastomosis (MC-BEA) was performed safely with no perioperative complications, demonstrating its effectiveness as a time-saving surgical option.

The procedure resulted in a median time for anastomosis formation of just 19 days, and while most patients had successful outcomes, 4.9% experienced anastomotic stricture requiring further surgery, indicating a low but notable risk of complications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Magnetic Anastomosis for Biliojejunostomy: First Prospective Clinical Trial. Liu, XM., Yan, XP., Zhang, HK., et al.[2019]

Magnetic compression anastomosis (magnamosis) was successfully tested in a porcine model for esophageal atresia, showing that it is technically feasible to create sutureless anastomoses in the esophagus.

Out of five pigs, three survived until the study endpoint with well-formed anastomoses, indicating potential for clinical application in humans, although initial attempts faced challenges such as leaks and aspiration.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Magnetic compression anastomosis (magnamosis) in a porcine esophagus: Proof of concept for potential application in esophageal atresia. Bruns, NE., Glenn, IC., Craner, DR., et al.[2019]

The magnetic compression anastomosis (magnamosis) technique demonstrated safety and effectiveness in a study involving 21 young adult pigs, with all anastomoses remaining patent and well healed after 1 to 6 weeks.

The custom magnetic device provided immediate patency and achieved burst strengths equal to or greater than traditional stapled anastomoses, suggesting it could be a promising minimally invasive alternative for surgical procedures in humans.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Magnamosis II: Magnetic compression anastomosis for minimally invasive gastrojejunostomy and jejunojejunostomy. Pichakron, KO., Jelin, EB., Hirose, S., et al.[2010]

The Magnamosis device successfully created intestinal anastomoses in 5 patients without the use of sutures or staples, demonstrating its feasibility in complex surgical cases.

At a median follow-up of 13 months, there were no complications related to the anastomosis, such as leaks or strictures, indicating a promising safety profile for this innovative technique.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Magnetic Compression Anastomosis (Magnamosis): First-In-Human Trial. Graves, CE., Co, C., Hsi, RS., et al.[2017]

The MAGNAMOSIS system successfully performed hybrid endoscopic colorectal anastomoses in 16 swine, demonstrating feasibility with a mean operating time of 71 minutes and effective burst pressure results, indicating strong anastomosis integrity.

The study found that the magnetic anastomoses had similar histological outcomes and inflammation levels compared to conventional stapled anastomoses, suggesting that MAGNAMOSIS is a reliable alternative for colorectal surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

MAGNAMOSIS IV: magnetic compression anastomosis for minimally invasive colorectal surgery. Wall, J., Diana, M., Leroy, J., et al.[2013]

Citations

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

Magnetic compression anastomosis system. A magnetic ... A magnetic compression anastomosis system is a surgical device used for the creation of anastomoses in minimally invasive and laparoscopic ...

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

First-in-human side-to-side linear magnetic compression ... A novel minimally invasive magnetic compression anastomosis system that requires no fixation, enterotomy closure, or permanent implant seems to mitigate major ...

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

First-in-Human Side-to-Side Duodenoileal Bipartition for ... Anastomosis creation using a novel magnetic compression technique may provide an alternative minimally invasive approach to gastrointestinal ...

4. clinicaltrials.gov clinicaltrials.gov/study/NCT06613711

Study Details | NCT06613711 | MagDI Italian Study The objective of the MagDI Italy Study is to evaluate the feasibility / performance, safety, and initial efficacy of the MagDI System in eligible participants ...

5. soard.org soard.org/article/S1550-7289(23)00762-1/fulltext

Side-to-side magnetic duodeno-ileostomy in adults with ... The study aim was to evaluate the feasibility, safety, and effectiveness of primary and revisional side-to-side duodeno-ileostomy (DI) ...

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

First-in-Human Side-to-Side Magnetic Compression Duodeno ... First-in-human compression anastomosis with the magnet system was feasible and safe. • Magnetic s-t-s duodeno-ileostomy + SG achieved excellent ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10453638/

Magnetic Compression Anastomosis–Past Experience and ... Clinical MCA was found to be successful in over 87% of cases. MCA limitations concerning anastomotic failure and scarring were thought to be mostly due to ...

8. sciencedirect.com sciencedirect.com/science/article/pii/S1550728923007621

Side-to-side magnetic duodeno-ileostomy in adults with ... Among 64 AEs reported in the study, complications were significantly fewer in the MagDI-after-SG group (10.9%, 7/64) than in the MagDI + SG cohort (89.1%, 57/64) ...