Obesity Clinical Trial - Endoscopic Gastric Mucosal Devitalization (GMD)

Status Completed

Clinical Trial Summary

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.

Clinical Trial Description

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 parts. 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. Part 2: Aims to confirm that the optimal color of the tissue identified by part 1 corresponds to selective mucosal devitalization in the in vivo setting by histopathologic examination. For this, patients will be enrolled in the study after being scheduled to undergo vertical sleeve gastrectomy (VSG). GMD will be performed three days prior to the VSG, and the excised tissue including devitalized gastric mucosa will be evaluated. The degree and correlation of devitalization with mucosal discoloration will be assessed. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT03638843
Study type	Interventional
Source	Johns Hopkins University
Contact
Status	Completed
Phase	N/A
Start date	September 25, 2020
Completion date	July 8, 2021

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Endoscopic Gastric Mucosal Devitalization (GMD) as a Primary Obesity Therapy - Part 2

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms