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New treatment option for Gastric Outlet Obstruction
Official title GT Metabolic Magnet System in Adults With Gastrointestinal Disorders
ClinicalTrials.gov ID: NCT07317076
What this study is testing
- What it's testing
- 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.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Indicated for gastrointestinal surgery requiring a gastric and/or small bowel anastomosis, without need for immediate lumen patency, and meets one of...
- 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.
You likely can't join if
- Other gastrointestinal or abdominal surgeries planned concurrently or within the study follow-up period (e.g., bariatric surgery such as sleeve...
- Prior surgery, trauma, prostheses, disease or genetic expression which prevent or contraindicate the anastomosis or study procedure, including...
- 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...
- Unhealed ulcers, bleeding lesions, tumor, diseased tissue or any other lesion at or distal to the target Magnet deployment sites.
See the full eligibility 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.
- 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 treatment 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...
The study team makes the final eligibility decision.
Where it's taking place
- Westmount, Quebec, Canada
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Westmount, Quebec, Canada. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.