Obesity Clinical Trial
Official title:
Safety and Feasibility of HybridAPC for Gastric Mucosal Ablation in the Management of Patients With Class III Obesity
This study is intended to investigate safety and feasibility of a new weight loss technique called Gastric Mucosal Ablation (GMA) that does not require surgery, but can be achieved using an endoscopic procedure. Previous studies have suggested that weight loss after vertical sleeve gastrectomy (VSG) is partly due to the removal of normal stomach tissue suspected of having hormonal function. The study will investigate the minimally invasive treatment of obesity Class III participants by means of argon plasma coagulation (APC) in combination with waterjet submucosal injection using HybridAPC. As primary endpoint device or procedure related occurrence of complications according to Clavien-Dindo classification will be determined. After signing the informed consent the doctor and research team will determine if the participant meets all requirements for this study. If a participant is confirmed to be a suitable candidate additional tests will be performed prior to the first application of GMA to assess the health status of the participant prior to treatment. During the screening and baseline visit the medical history and the medications of the participant will be reviewed. After the treatments the participants will be followed for up to 6 months to assess the outcome of the GMA procedure.
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