ABLATE WEIGHT 2 (Single-Stage Fundic Ablation Plus ESG for Weight Loss) (NCT05992103) | Clinical Trial Compass
UnknownNot Applicable
ABLATE WEIGHT 2 (Single-Stage Fundic Ablation Plus ESG for Weight Loss)
United States10 participantsStarted 2023-09-14
Plain-language summary
The purpose of this research is to investigate the combined effects of fundic ablation (FA) and endoscopic sleeve gastroplasty 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. When fundic mucosal ablation is 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 within the same endoscopic session should be made available to patients as part of a comprehensive weight loss strategy.
Who can participate
Age range21 Years – 65 Years
SexALL
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Inclusion criteria
✓. Subjects aged 21-65
✓. Body mass Index (BMI) ≥30 kilograms per square meter (kg/m²), or ≤50 kg/m²
✓. History of at least one unsuccessful dietary effort to lose body weight
✓. Willing and able to participate in the study procedures
✓. Understand and voluntarily sign the informed consent
✓. Approved ESG candidate at True You Weight Loss
✓. Access to internet
✓. Reliable transportation to and from Cary, North Carolina surrounding area
Exclusion criteria
✕. Younger than 21 years of age
✕. Older than 65 years of age
✕. Patients on any medications or supplements including those that may influence cholecystokinin (CCK), glucose, growth hormone, insulin and/or somatostatin levels
✕. History of any stomach manipulation (including repair of hiatal hernia)
✕. History of disordered eating
✕. Patients who do not give their consent to the enrollment in the study or are incompetent, unconscious or unable to express their consent for any reason
✕. Hemoglobin A1c \> 7.0 or any patient with symptoms suggestive of gastroparesis or a formal diagnosis of gastroparesis