GT Metabolic Magnet System to create side-to-side connections in the stomach or small intestine

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This interventional trial uses the GT Metabolic Magnet System as a surgical tool to create side-to-side compression anastomoses in adults with GOO, partial small-bowel obstruction, or SMAS. The device is placed during a planned procedure to compress two bowel walls and form a controlled anastomosis, with device behavior and patient outcomes tracked through follow-up. Key outcomes include device performance measures (anastomotic formation and patency) and safety endpoints such as leak rates and adverse events. The study is conducted at a single center in Westmount, Quebec, and enrolls adults who meet specified inclusion and exclusion criteria.

Why it matters

Who can join: the full rules

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.

Where it's running

• Westmount Surgical Center
  Westmount, Quebec, Canada Recruiting

Study contacts

• Study coordinator: Lisa Griffin Vincent, PhD, MA
• Email: clinical@gtmetabolic.com
• Phone: +1 763-200-1416

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.