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

Trial Summary

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 data supports the effectiveness of the MagDI System treatment for intestinal surgery?

The MagDI System, which uses magnetic compression anastomosis, has shown effectiveness in creating connections in the intestines without the need for stitches or staples. Studies have demonstrated its feasibility and safety in various gastrointestinal surgeries, including weight loss procedures and minimally invasive colorectal surgeries, suggesting it could be a promising alternative to traditional methods. ^{1 2 3 4 5}

Is the MagDI System safe for use in humans?

The MagDI System, also known as magnetic compression anastomosis, has been shown to be safe in several studies involving different types of intestinal surgeries. These studies have demonstrated its safety in humans and animals, with no significant issues reported. ^{1 2 3 5 6}

How is the MagDI System treatment different from other treatments for intestinal surgery?

The MagDI System is unique because it uses magnetic compression anastomosis, which involves self-centering magnetic rings to connect intestinal tissues without the need for sutures or staples, making the procedure less invasive and potentially reducing complications like bleeding and leaks. ^{1 2 3 4 5}

What is the purpose of this trial?

The objective of the MagDI Canada study is to evaluate the performance and safety of the MagDI System in eligible participants who are indicated for a duodeno-ileal (small bowel) side-to-side anastomosis procedure for partial intestinal diversion as one example of a small bowel clinical procedure requiring a side-to-side anastomosis. The secondary objective includes initial efficacy of the duodeno-ileal diversion using the MagDI System.

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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 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 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]

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]

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]

References

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

Magnetic Compression Anastomosis (Magnamosis): First-In-Human Trial. [2017]

2. Germany pubmed.ncbi.nlm.nih.gov

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

3. Germany pubmed.ncbi.nlm.nih.gov

MAGNAMOSIS IV: magnetic compression anastomosis for minimally invasive colorectal surgery. [2013]

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

Magnetic compression anastomosis (magnamosis) in a porcine esophagus: Proof of concept for potential application in esophageal atresia. [2019]

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

Magnamosis II: Magnetic compression anastomosis for minimally invasive gastrojejunostomy and jejunojejunostomy. [2010]

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

Magnetic Anastomosis for Biliojejunostomy: First Prospective Clinical Trial. [2019]