An interventional study of Magnet System, DI Biofragmentable in Obesity and Type 2 Diabetes, sponsored by GT Metabolic Solutions, Inc.. Completed at 1 site in Czechia. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2025-12-23.
Sponsored by GT Metabolic Solutions, Inc. · Not applicable, Interventional, and Treatment
The purpose of this clinical research study is to evaluate the feasibility/performance, safety and initial efficacy of the GT Metabolic Solutions DI Biofragmentable Magnetic Anastomosis System (Magnet System, DI Biofragmentable and hereafter referred to as the DI Magnet System) for creation of a side-to-side jejuno-ileal anastomosis in adults with obesity and type 2 diabetes mellitus (T2DM).
The purpose of this clinical research study is to evaluate the feasibility/performance, safety and initial efficacy of the GT Metabolic Solutions DI Biofragmentable Magnetic Anastomosis System (Magnet System, DI Biofragmentable and hereafter referred to as the DI Magnet System) for creation of a side-to-side jejuno-ileal anastomosis in adults with obesity and type 2 diabetes mellitus (T2DM). This partial diversion of intestinal contents from jejunum to the ileum is intended to facilitate weight management/loss and improve metabolic outcomes. Side-by side anastomoses are currently created by sutures, staples, and anastomotic compression devices. This study explores a partial jejuno-ileal diversion procedure creating a side-to-side anastomosis with magnetic compression anastomosis.
6,296 studies on the registry are indexed under Obesity; 1,692 are open to participants now.
This study's enrollment of 9 is below the median of 78 across 4,878 interventional studies indexed under Obesity.
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Exclusion Criteria:
GT Metabolic Solutions DI Biofragmentable Magnetic Anastomosis System (Magnet System, DI Biofragmentable)
Device: Magnet System, DI Biofragmentable
Anastomoses achieved by magnetic compression.
Feasibility and performance of the side-to-side anastomosis for jejuno-ileal diversion using the DI Magnet System.
The jejuno-ileal diversion will be considered feasible if it results in successful: * Placement of the Magnet System (≥ 90% alignment of magnets); and * Creation of a patent anastomosis confirmed radiologically, and * Passage of magnets without any surgical re-interventions. The primary endpoint will be met if the feasibility/performance is confirmed in ≥ 80% of enrolled and treated participants.
Time frame: From date of study index procedure through 90 days
Safety of the DI Magnet System
Freedom from serious adverse events related to the study device or study device procedure requiring additional emergency surgery or re-intervention, including: * All-cause mortality * Intestinal perforation and/or peritonitis * Intestinal obstruction * Life-threatening bleeding * Incidence of device malfunctions
Time frame: Procedure, Day 90, Day 180, Day 360
Plan to share: No
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This study is completed, as verified in Dec 2025. You cannot join it, but the record below documents what was studied.
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GT Metabolic Solutions, Inc.