Obesity Clinical Trial
Official title:
Creation of Side-to-Side Compression Anastomosis Using the GT Metabolic Solutions DI Bio-fragmentable Magnetic Anastomosis System to Achieve Duodeno-Ileostomy Diversion in Adults With Obesity and Type 2 Diabetes Mellitus
The purpose of this clinical research study is to evaluate the feasibility of the GT Metabolic Solutions DI Bio-fragmentable Magnetic Anastomosis System (MAGNET System, DI Bio-fragmentable) for creation of a side-by-side anastomosis duodeno-ileostomy in obese adults.
The purpose of this clinical research study is to evaluate the feasibility of the GT Metabolic Solutions DI Bio-fragmentable Magnetic Anastomosis System (MAGNET System, DI Bio-fragmentable) for creation of a side-to-side anastomosis duodeno-ileostomy in obese adults. This partial diversion of intestinal contents from duodenum to the ileum is intended to facilitate weight management/loss in obese adults with type 2 diabetes mellitus (T2DM) and improve metabolic outcomes in obese adults with type 2 diabetes mellitus (T2DM). Side-by-side anastomoses are currently created by sutures, staples, and anastomotic compression devices. A predicate procedure is the single-anastomosis duodeno-ileostomy (SADI) procedure. ;
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