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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
9
Anastomoses achieved by magnetic compression.
OB KLINIKA a.s.
Prague, Czechia
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
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