Compression Anastomosis Using the GT Metabolic Magnet System in Adults With Gastrointestinal Disorders (GT Metabolic Magnet System Study)
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- GT Metabolic Solutions, Inc.
- Enrollment
- 35
- Locations
- 1
- Primary Endpoint
- Magnet Placement
Study Overview
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.
Detailed Description
Evaluate the performance and safety of the Magnet System as a surgical tool for anastomosis in participants who have partial small bowel obstruction, SMAS, or GOO due to their similarities (they all involve a physical impediment (e.g., compression of the intestinal lumen) and/or mechanical blockage of the GI tract).
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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:
- •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.
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.
Arms & Interventions
Magnet System
GT Metabolic Magnet System comprised of GT Metabolic Magnet System ("Magnet System")
Intervention: Magnet System (Device)
Outcomes
Primary Outcomes
Magnet Placement
Time Frame: 1 day
Placement and connection of two intraluminal Magnet.
Natural Magnet Passage
Time Frame: 90 days
Successful passage of magnets without surgical reintervention
Anastomosis Patency
Time Frame: 90 days
Creation of a patent anastomosis confirmed radiologically.
Secondary Outcomes
No secondary outcomes reported