Obesity Clinical Trial
Official title:
Endoscopic Gastric Mucosal Devitalization (GMD) as a Primary Obesity Therapy
Rapid metabolic improvements seen with sleeve gastrectomy are likely a result of changes in gastric origin. The gastric mucosa is an endocrine organ that regulates satiation pathways and is a complex regulator of food intake as well as lipid and glucose metabolism. This study aims to assess the efficacy and safety of endoscopic selective gastric mucosal devitalization (GMD) for the management of obesity and its related comorbidities.
Endoscopic approaches to obesity may help fulfill the unmet need of over half the US adult
population that would benefit from therapy for obesity but are not receiving it. Endoscopic
approaches to obesity have the potential to be more efficacious than antiobesity medications
and have a lower risk-cost profile compared with bariatric surgery.
Endoscopic approaches to obesity need to be increasingly modeled on the proposed mechanisms
contributing to the benefits of bariatric surgery.
The investigators seek to decipher if the gastric mucosa is an independent regulator of food
intake, body weight, lipid and glucose metabolism and serum gut hormones. The investigators
also wish to ascertain if selective devitalization of the gastric mucosa, without alteration
in gastric volume, will improve obesity related comorbidities.
This study will be divided into 3 phases. The purpose of completing the 3 phases is to
develop a minimally invasive weight loss technique that is effective, safe and ready for more
rigorous assessment via a future randomized control trial.
Objectives:
Overall:
To assess the efficacy and safety of gastric mucosal devitalization for the management of
obesity and its related comorbidities
Phase 1:
On an ex vivo specimen, identify the optimal color of the tissue indicating that the gastric
mucosa has been sufficiently treated such that selective mucosal devitalization has occurred.
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