Actively Recruiting
Compression Anastomosis Using the GT Metabolic Magnet System in Adults With Gastrointestinal Disorders (GT Metabolic Magnet System Study)
Led by GT Metabolic Solutions, Inc. · Updated on 2026-05-19
35
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the performance and safety of the GT Metabolic Magnet System, a device designed to create side-to-side compression anastomosis in the stomach and/or small bowel. The study focuses on adults with gastrointestinal disorders such as partial small bowel obstruction, superior mesenteric artery syndrome (SMAS), or gastric outlet obstruction (GOO), conditions that involve physical or mechanical blockage of the gastrointestinal tract. These similarities make the Magnet System a potential surgical tool to address these issues as part of clinical treatment. Participants will receive treatment using the GT Metabolic Magnet System, which aims to form a magnetic compression anastomosis for intestinal diversion. The procedure involves placing magnets to create the anastomosis without the immediate need for lumen patency. The study includes monitoring the placement of the magnet on the first day, observing natural magnet passage, and assessing anastomosis patency over a 90-day period. This interventional study does not use blinding or randomization and focuses on the single experimental device. During the study, participants will be closely monitored through evaluations measuring magnet placement and passage, as well as the condition of the anastomosis up to 90 days post-procedure. Researchers will assess safety and device performance. Participants must follow study requirements, including surgical clearance and contraception use if applicable. The total duration includes the initial procedure and follow-up assessments to ensure proper device function and participant safety.
CONDITIONS
Brief Title
GT Metabolic Magnet System in Adults With Gastrointestinal Disorders
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Indicated for gastrointestinal surgery requiring a gastric and/or small bowel anastomosis without need for immediate lumen patency
- Diagnosis of superior mesenteric artery syndrome (SMAS), gastric outlet obstruction (GOO), or partial small bowel obstruction
- Meets surgical clearance requirements as per the investigator's institution
- If female of child-bearing potential, agrees to use contraception for the duration of the study
You will not qualify if you...
- Planned gastrointestinal or abdominal surgeries concurrently or within the follow-up period (e.g., bariatric surgery such as sleeve gastrectomy)
- Prior surgery, trauma, prostheses, disease, or abnormalities preventing anastomosis or study procedure, including scarring or abnormal anatomy at target sites
- Any anatomical anomaly preventing gastrointestinal access by gastroscope, endoscope, catheters, or related device placement techniques
- Conditions precluding laparoscopic surgery
- Presence of implantable pacemaker, defibrillator, or metallic implants that could interfere with the magnetic implant or procedures
- Unhealed ulcers, bleeding lesions, tumors, diseased tissue, or lesions at or beyond the magnet deployment sites
- Need for immediate lumen patency during anastomosis formation
- History of prior or current malignancy
- Expected need for MRI within first 3 months post-procedure or before confirmed magnet expulsion
- Known allergies to device components or contrast media
- Pregnant, lactating, or planning pregnancy during the study and follow-up period
- Concurrent participation in other investigational drug, biologic, or device studies
- Other anatomical, medical, social, or psychological conditions limiting ability to participate or comply with follow-up requirements
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 1 day
Participants undergo placement of the GT Metabolic Magnet System as a surgical tool for intestinal anastomosis.
1 visit (in-person)
Duration - Up to 90 days
Participants are monitored for natural magnet passage and anastomosis patency following the magnet system placement.
Visits scheduled as needed for follow-up within 90 days
Trial Site Locations
Total: 1 location
1
Westmount Surgical Center
Westmount, Quebec, Canada, H3Z 2P9
Actively Recruiting
Research Team
L
Lisa Griffin Vincent, PhD, MA
J
Josh Schumacher
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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