ABLATE WEIGHT (Ablation Plus ESG for Weight Loss)
Status unconfirmed · Not applicable
Conditions studied: Obesity
In brief
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.
Key facts
- Study ID
- NCT05578703
- Run by
- True You Weight Loss
- People needed
- 10
- Starts
- 2022-11-09
- Expected to finish
- 2026-06-01
- Last updated by the study team
- 2024-05-14
Who can join
Age: 21 and older, up to 65. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- 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 TYWL
- Access to internet
- Reliable transportation to and from Cary, North Carolina surrounding area
You may not qualify if…
- 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
- Milk and/or soy allergies
- 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
- Patients taking the following medications known to impair gastric accommodation: buspirone, mirtazapine
- Patients taking the following medications known to accelerate or impair gastric emptying: Reglan (metoclopramide), Zelnorm (tegaserod), Motegrity (prucalopride), erythromycin, Motilium (domperidone), opiates, anticholinergic agents
- Patients who are pregnant or who plan to become pregnant during study duration
- Use of non-steroidal anti-inflammatory medications without the ability to stop these during study duration
- Patients on chronic anticoagulation
- History of functional gastrointestinal disorder, including functional dyspepsia, irritable bowel syndrome, or other syndromes known to affect gastric sensorimotor function.
- Concurrent use of weight loss medications.
Where it is running
- True You Weight Loss — Cary, North Carolina, United States
Full record on ClinicalTrials.gov
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