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Recruiting NCT07317076

GT Metabolic Magnet System in Adults With Gastrointestinal Disorders

Trial Parameters

Condition Gastric Outlet Obstruction
Sponsor GT Metabolic Solutions, Inc.
Study Type INTERVENTIONAL
Phase N/A
Enrollment 35
Sex ALL
Min Age 18 Years
Max Age N/A
Start Date 2025-12-09
Completion 2026-11
Interventions
Magnet System

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.

Eligibility 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 / endo

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