GT Metabolic Magnet System to create side-to-side connections in the stomach or small intestine
Compression Anastomosis Using the GT Metabolic Magnet System in Adults With Gastrointestinal Disorders (GT Metabolic Magnet System Study)
This study will test whether the GT Metabolic Magnet System can safely create side-to-side connections in the stomach or small intestine for adults with gastric outlet obstruction, partial small bowel obstruction, or superior mesenteric artery syndrome.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 35 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | GT Metabolic Solutions, Inc. Industry-sponsored |
| Locations | 1 site (Westmount, Quebec) |
| Trial ID | NCT07317076 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Adults cleared for gastrointestinal surgery who require a gastric and/or small-bowel side-to-side anastomosis for SMAS, gastric outlet obstruction, or partial small-bowel obstruction are ideal candidates.
Not a fit: Patients needing immediate lumen patency, those with prior surgeries, scarring, abnormal anatomy, contraindications to GI access, or planned concurrent abdominal procedures are unlikely to benefit from this approach.
Why it matters
Potential benefit: If successful, the device could provide an alternative method to create anastomoses that may reduce operative trauma and improve recovery for selected patients.
How similar studies have performed: Magnetic compression anastomosis has appeared in prior clinical and preclinical reports with promising results, but device-specific human data remain limited.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Westmount, Quebec
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.