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ABLATE WEIGHT (Ablation Plus ESG for Weight Loss)
Sponsor: True You Weight Loss
Summary
The purpose of this research is to investigate the effects of fundic ablation (FA) on circulating plasma ghrelin, satiation, and total body weight loss, as well as the incidence of adverse events. This procedure will be carried out with the HybridAPC (ERBE Elektromedizin GmbH, Tübingen, Germany). The HybridAPC instrument creates an electric current to deliver a safe amount of thermal injury to a portion of the stomach known as the gastric fundus. This thermal injury will target a hormone called ghrelin which is the only known hormone linked to increasing appetite, calorie intake, and weight gain. This procedure is designed to target the bodily effects of appetite control and gastric sensory and motor functions which cause the feeling of fullness and satiation. The fundic mucosal ablation is not typically done prior to the endoscopic sleeve gastroplasty procedure. When fundic mucosal ablation is sequentially paired with endoscopic sleeve gastroplasty (ESG), this combined investigational approach may lead to decreased fasting ghrelin levels, improved satiation, and greater total body weight loss than traditional ESG. This study will help determine if the combined impact of FA with ESG should be made available to patients as part of a comprehensive weight loss strategy.
Official title: Gastric Fundus Ablation Plus Endoscopic Sleeve Gastroplasty for Weight Loss
Key Details
Gender
All
Age Range
21 Years - 65 Years
Study Type
INTERVENTIONAL
Enrollment
10
Start Date
2022-11-09
Completion Date
2026-06
Last Updated
2024-05-14
Healthy Volunteers
Yes
Conditions
Interventions
Fundic Ablation Sequentially in Combination with Endoscopic Sleeve Gastroplasty
Fundic mucosal ablation followed by endoscopic sleeve gastroplasty in the treatment of adults with obesity
Fundic Mucosal Ablation with ERBE HybridAPC
Fundic mucosal ablation utilizing approved ERBE HybridAPC
Apollo ESG
Using only Apollo ESG as approved per label
Locations (1)
True You Weight Loss
Cary, North Carolina, United States