NCT03526263

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

• 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 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.

Conditions

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

Interventions

Type	Name	Description
PROCEDURE	Gastric mucosal devitalization	During routine laparoscopic sleeve gastrectomy surgery, once the greater curvature of the stomach is excised as per normal surgical technique, the investigators will take the specimen out and perform an ablation ex-vivo, with the intention of performing selective mucosal devitalization. This specimen will then be transported to pathology lab for analysis.

Timeline

• Start date: 2018-06-07
• Primary completion: 2018-11-29
• Completion: 2018-11-29
• First posted: 2018-05-16
• Last updated: 2019-09-24

Locations

1 site across 1 country: United States