NCT03638843

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 6 (actual)
• Sponsor: Johns Hopkins University · Academic / Other
• Sex: All
• Age: 28 Years – 60 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Obesity
• Obesity, Morbid
• Obesity; Endocrine
• Bariatric Surgery Candidate

Interventions

Type	Name	Description
PROCEDURE	Gastric mucosal devitalization	Gastric mucosal devitalization is an endoscopic procedure which uses argon plasma coagulation to result in selective damage to the gastric mucosa and submucosa.

Timeline

• Start date: 2020-09-25
• Primary completion: 2021-07-08
• Completion: 2021-07-08
• First posted: 2018-08-20
• Last updated: 2021-07-20

Locations

1 site across 1 country: United States