NCT07317076 GT Metabolic Magnet System in Adults With Gastrointestinal Disorders
| NCT ID | NCT07317076 |
| Status | Recruiting |
| Phase | — |
| Sponsor | GT Metabolic Solutions, Inc. |
| Condition | Gastric Outlet Obstruction |
| Study Type | INTERVENTIONAL |
| Enrollment | 35 participants |
| Start Date | 2025-12-09 |
| Primary Completion | 2026-11 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 35 participants in total. It began in 2025-12-09 with a primary completion date of 2026-11.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07317076 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Gastric Outlet Obstruction. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07317076 currently recruiting?
Yes, NCT07317076 is actively recruiting participants. Contact the research team at clinical@gtmetabolic.com for enrollment information.
Where is the NCT07317076 trial being conducted?
This trial is being conducted at Westmount, Canada.
Who is sponsoring the NCT07317076 clinical trial?
NCT07317076 is sponsored by GT Metabolic Solutions, Inc.. The trial plans to enroll 35 participants.