GT Metabolic Magnet System in Adults With Gastrointestinal Disorders
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorGT Metabolic Solutions, Inc.
About this trial
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.
Eligibility criteria
Qualifiers
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.
Disqualifiers
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.
Trial design
Treatments tested in this trial
- Magnet System
Treatment groups
35 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov