Recruiting

GT Metabolic Magnet SystemGT Metabolic Magnet System in Adults With Gastrointestinal Disorders

Sponsor:

GT Metabolic Solutions, Inc.

Code:

NCT07317076

Conditions

Gastric Outlet Obstruction

Small Bowel Obstruction

Superior Mesenteric Artery Syndrome

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Magnet System

Study Details

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.

Conditions

Gastric Outlet Obstruction

Small Bowel Obstruction

Superior Mesenteric Artery Syndrome

Study ID

NCT07317076

Start date

Dec 9, 2025

Status verified date

May, 2026

Completion date

Nov, 2026

Anticipated

Primary completion date

Nov, 2026

Anticipated

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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 Design

Enrollment

35 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Magnet System

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

Interventions

Magnet System

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

Primary outcome measure

Magnet Placement [ Time Frame: 1 day ]
Natural Magnet Passage [ Time Frame: 90 days ]
Anastomosis Patency [ Time Frame: 90 days ]

Central Contacts and Locations

Central contacts

Lisa Griffin Vincent, PhD, MA

+1 763-200-1416 clinical@gtmetabolic.com

Josh Schumacher

+1 763-200-1416 clinical@gtmetabolic.com

Locations

Westmount Surgical Center

Recruiting

Westmount, Quebec, Canada, H3Z 2P9

Contacts

Gismonde Gnanhoue

(514)-922-5055 gnanhoue.gismonde@wssurgical.com

Principal Investigator:

Michel Gagner, MD

More Information

Sponsor

GT Metabolic Solutions, Inc.

Last update posted

May 19, 2026

Last verified

May, 2026

Keywords

Magnet System
GT Metabolic Solutions, Inc.

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by GT Metabolic Solutions, Inc. on 2026-05-19.