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Procedure

MagDI System for Intestinal Surgery

N/A

Recruiting

Research Sponsored by GT Metabolic Solutions, Inc.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Participant agrees to refrain from any type of additional bariatric or reconstructive surgery that would affect body weight for the duration of the study

Between 18-65 years of age, at the time of informed consent

Must not have

Requires chronic anticoagulation therapy (except aspirin)

Any anomaly precluding orogastric access by gastroscope and catheters, and manipulation techniques

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from date of study index procedure through 360 days.

Awards & highlights

Summary

This trial aims to test a new system called MagDI in patients who need a specific type of intestinal surgery. The study will assess how well the MagDI System works and if it is safe for patients

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Potential side effects may include complications related to the Magnet System or DI Biofragmentable device used in surgery, such as infection, bleeding, or issues at the site where intestines are joined.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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

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I am between 18 and 65 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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

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I have no issues that would prevent the use of a gastroscope or catheters in my stomach.

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I have been diagnosed with Helicobacter pylori or have an active ulcer.

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My type 2 diabetes is not well-controlled.

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I have a large hiatal hernia.

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I use injectable insulin.

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I have inflammatory bowel disease or diverticulitis.

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I have Type 1 diabetes.

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I have high blood pressure, cholesterol issues, or sleep apnea that isn't well-managed.

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My acid reflux does not improve with treatment.

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I have Barrett's disease.

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I have no conditions that prevent minimally invasive surgeries.

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I haven't had any surgery or procedures within 30 days before or after joining the study.

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I have no unhealed wounds or bleeding at the site for the Magnet deployment.

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I have had surgery on my intestines, colon, or duodenum.

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I don't have any conditions or past surgeries that would prevent me from undergoing the procedure.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from date of study index procedure through 360 days.

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from date of study index procedure through 360 days.

This trial's timeline: 3 weeks for screening, Varies for treatment, and from date of study index procedure through 360 days. for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Performance of the side-to-side anastomosis for duodeno-ileal diversion using the MagDI System.

Safety of the MagDI System

Trial Design

1Treatment groups

Experimental Treatment

Group I: Magnet System, DI BiofragmentableExperimental Treatment1 Intervention

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

0 / 18Eligibility criteria met

Find a Location

Who is running the clinical trial?

GT Metabolic Solutions, Inc.Lead Sponsor

7 Previous Clinical Trials

232 Total Patients Enrolled

~40 spots leftby Mar 2026

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