GT Metabolic Magnet System in Adults With Gastrointestinal Disorders

NCT ID: NCT07317076

Last Updated: 2026-01-05

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 35 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-12-09
• Study Completion Date: 2026-11-30

Brief Summary

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.

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).

Conditions

Gastric Outlet Obstruction; Small Bowel Obstruction; Superior Mesenteric Artery Syndrome

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Magnet System

GT Metabolic Magnet System comprised of GT Metabolic Magnet System ("Magnet System")

Group Type: EXPERIMENTAL

Magnet System

Intervention Type: DEVICE

Magnetic compression anastomoses for intestinal diversion in subjects with small bowel obstruction, gastric outlet obstruction, or superior mesenteric artery syndrome.

Interventions

Magnet System

Magnetic compression anastomoses for intestinal diversion in subjects with small bowel obstruction, gastric outlet obstruction, or superior mesenteric artery syndrome.

Intervention Type: DEVICE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

GT Metabolic Solutions, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Westmount Surgical Center

Westmount, Quebec, Canada

Site Status: RECRUITING

Countries

Canada

Central Contacts

Lisa Griffin Vincent, PhD, MA

Role: CONTACT

clinical@gtmetabolic.com

+1 763-200-1416

Josh Schumacher

Role: CONTACT

clinical@gtmetabolic.com

+1 763-200-1416

Facility Contacts

Gismonde Gnanhoue

Role: primary

gnanhoue.gismonde@wssurgical.com

(514)-922-5055

Other Identifiers

GTM-020

Identifier Type: -

Identifier Source: org_study_id