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.
Age range
21 Years – 65 Years
Sex
ALL
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Change from Baseline in Fasting Plasma Ghrelin Levels
Timeframe: Baseline, Month 1, Month 2, Month 3, Month 6, Month 9, Month 12, and Month 18
Change from Baseline in Timed Standardized Nutrient Drink Test
Timeframe: Baseline, Month 1, Month 2, Month 3, Month 6, Month 9, Month 12, and Month 18
Change from Baseline in Gastroparesis Cardinal Symptom Index (GCSI)
Timeframe: Baseline, Month 1, Month 2, Month 3, Month 6, Month 9, Month 12, and Month 18
Change from Baseline in Daily Eats: Measuring Daily Eating Factors (DAILY EATS)
Timeframe: Baseline, Month 1, Month 2, Month 3, Month 6, Month 9, Month 12, and Month 18
Percent Change in Total Body Weight Loss (TBWL) from Baseline
Timeframe: Baseline, Month 1, Month 2, Month 3, Month 4, Month 5, Month 6, Month 7, Month 8, Month 9, Month 10, Month 11, Month 12, Month 13, Month 14, Month 15, Month 16, Month 17, and Month 18
Change from Baseline in Weight Efficacy Life-Style Questionnaire Short Form (WEL-SF) composite score
Timeframe: Baseline, Month 1, Month 2, Month 3, Month 6, Month 9, Month 12, and Month 18