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

NCT03526263 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 6

Last updated 2019-09-24

No results posted yet for this study

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.

Conditions

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

Interventions

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.

Sponsors & Collaborators

Principal Investigators

  • Vivek Kumbhari, MD · Johns Hopkins University

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
28 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-06-07
Primary Completion
2018-11-29
Completion
2018-11-29

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03526263 on ClinicalTrials.gov