GT Metabolic Magnet System in Adults With Gastrointestinal Disorders

May 18, 2026 updated by: GT Metabolic Solutions, Inc.

Compression Anastomosis Using the GT Metabolic Magnet System in Adults With Gastrointestinal Disorders (GT Metabolic Magnet System Study)

Evaluate the performance and safety of the GT Metabolic Magnet System for the creation of side-to-side compression anastomosis in the stomach and/or small bowel in conditions requiring an anastomosis as part of the underlying clinical treatment.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Evaluate the performance and safety of the Magnet System as a surgical tool for anastomosis in participants who have partial small bowel obstruction, SMAS, or GOO due to their similarities (they all involve a physical impediment (e.g., compression of the intestinal lumen) and/or mechanical blockage of the GI tract).

Study Type

Interventional

Enrollment (Estimated)

35

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Canada
    • Quebec
      • Westmount, Quebec, Canada, H3Z 2P9
        • Recruiting
        • Westmount Surgical Center
        • Contact:
        • Principal Investigator:
          • Michel Gagner, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Indicated for gastrointestinal surgery requiring a gastric and/or small bowel anastomosis, without need for immediate lumen patency, and meets one of the following criteria:

    1. Superior mesenteric artery syndrome (SMAS); OR
    2. Gastric outlet obstruction (GOO); OR
    3. Partial small bowel obstruction.
  • Meets the surgical clearance requirements as governed by the investigator's institution.
  • If a child-bearing female, subject must commit to not becoming pregnant and agree to use contraception for the duration of the study.

Exclusion Criteria:

  • Other gastrointestinal or abdominal surgeries planned concurrently or within the study follow-up period (e.g., bariatric surgery such as sleeve gastrectomy).
  • Prior surgery, trauma, prostheses, disease or genetic expression which prevent or contraindicate the anastomosis or study procedure, including scarring and abnormal anatomy at the anastomosis sites.
  • Any anomaly precluding gastrointestinal access by gastroscope / endoscope, catheters, and associated manipulation techniques for device placement.
  • Any condition or disease that precludes laparoscopic surgery.
  • Implantable pacemaker, defibrillator, other active and/or metallic implant that may interfere with or be adversely impacted by a temporary magnetic implant (Magnet System) and associated procedures.
  • Unhealed ulcers, bleeding lesions, tumor, diseased tissue or any other lesion at or distal to the target Magnet deployment sites.
  • Any need for immediate lumen patency while the anastomosis is formed.
  • History of prior or current malignancy.
  • Expected need for Magnetic Resonance Imaging (MRI) within the first 3 months post-procedure (or before if Magnet expulsion is confirmed radiologically).
  • Known allergies to the device components (including the biofragmentable material PGLA or similar compounds) or contrast media.
  • Pregnant, lactating, or planning pregnancy during the clinical investigation and follow up period.
  • Currently participating in an investigational drug, biologic, or medical device or other interventional clinical study.
  • Presence of other anatomic or comorbid conditions, or medical, social or psychological conditions that, in the investigator's opinion, could limit the participant's ability to participate in the clinical investigation or to comply with follow-up requirements.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Magnet System
GT Metabolic Magnet System comprised of GT Metabolic Magnet System ("Magnet System")
Device: Magnet System
Magnetic compression anastomoses for intestinal diversion in subjects with small bowel obstruction, gastric outlet obstruction, or superior mesenteric artery syndrome.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Magnet Placement
Time Frame: 1 day
Placement and connection of two intraluminal Magnet.
1 day
Natural Magnet Passage
Time Frame: 90 days
Successful passage of magnets without surgical reintervention
90 days
Anastomosis Patency
Time Frame: 90 days
Creation of a patent anastomosis confirmed radiologically.
90 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

GT Metabolic Solutions, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 9, 2025

Primary Completion (Estimated)

November 1, 2026

Study Completion (Estimated)

November 1, 2026

Study Registration Dates

First Submitted

December 19, 2025

First Submitted That Met QC Criteria

December 19, 2025

First Posted (Actual)

January 5, 2026

Study Record Updates

Last Update Posted (Actual)

May 19, 2026

Last Update Submitted That Met QC Criteria

May 18, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GTM-020

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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