GT Metabolic Magnet System in Adults With Gastrointestinal Disorders

NCT07317076 | Recruiting

• 1 other identifier: GTM-020
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 1

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

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

Keywords

Magnet System; GT Metabolic Solutions, Inc.

Outcome Measures

Primary Outcomes (3)

• Magnet Placement

  Placement and connection of two intraluminal Magnet.

  1 day

• Natural Magnet Passage

  Successful passage of magnets without surgical reintervention

  90 days

• Anastomosis Patency

  Creation of a patent anastomosis confirmed radiologically.

  90 days

Study Arms (1)

Magnet System

EXPERIMENTAL

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

Device: Magnet System

Interventions

Magnet System DEVICE

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

Magnet System

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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:
• Superior mesenteric artery syndrome (SMAS); OR
• Gastric outlet obstruction (GOO); OR
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• GT Metabolic Solutions, Inc.: lead

Study Sites (1)

Westmount Surgical Center

Westmount, Quebec, H3Z 2P9, Canada

RECRUITING

MeSH Terms

Conditions

Gastric Outlet Obstruction; Superior Mesenteric Artery Syndrome

Condition Hierarchy (Ancestors)

Stomach Diseases; Gastrointestinal Diseases; Digestive System Diseases; Duodenal Obstruction; Duodenal Diseases; Intestinal Diseases

Central Study Contacts

Lisa Griffin Vincent, PhD, MA

CONTACT

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

Josh Schumacher

CONTACT

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 19, 2025
• First Posted: January 5, 2026
• Study Start: December 9, 2025
• Primary Completion (Estimated): November 1, 2026
• Study Completion (Estimated): November 1, 2026
• Last Updated: January 5, 2026

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)