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

Completed · Not applicable

Conditions studied: Obesity, Obesity, Morbid, Obesity; Endocrine, Bariatric Surgery Candidate

In brief

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.

Key facts

Study ID: NCT03638843
Run by: Johns Hopkins University
People needed: 6
Starts: 2020-09-25
Expected to finish: 2021-07-08
Last updated by the study team: 2021-07-20

Who can join

Age: 28 and older, up to 60. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

Patients scheduled to undergo vertical sleeve gastrectomy

You may not qualify if…

Age under 28 or older than 60
Insulin dependent Diabetes Mellitus
Suspected or biopsy confirmed liver cirrhosis
Significant ethanol consumption >21 drinks/week in men and >14 drinks/week in women
Presence of other chronic liver disease including hepatitis B-C, autoimmune hepatitis, alpha 1 antitrypsin deficiency, Wilson's disease, and hemochromatosis
Pregnant or breast-feeding
Patients who already have an intragastric balloon or other gastric implant
Patients with gastroesophageal reflux disease
Patients with previous gastric surgeries, altered gastrointestinal anatomy such as Billroth I, Billroth II, roux-en-y gastrectomy, roux-en-y hepaticojejunostomy, or any restrictive or bypass bariatric surgery
Patients with previous gastric embolization for obesity
Presence of inflammatory disorder of the gastrointestinal tract
Patients with active peptic ulcer disease
Patients with gastroesophageal varices
Presence of a large hiatal hernia (grade IV on Hills classification: large hiatal hernia and essentially no fold approximating the endoscope in the retroflexed view and where the lumen of the esophagus is gaping open allowing the squamous epithelium to be seen)
Structural abnormality in the esophagus or pharynx
Have major esophageal motility disorders as per the Chicago classification including achalasia, diffuse esophageal spasm, jackhammer esophagus, and Esophagogastric junction outflow obstruction
Mucosal or submucosal gastric mass that is clinically suspected to be of malignant nature
Severe clotting or bleeding disorder
Other medical condition that does not allow for endoscopic procedure
Severe psychiatric illness
Unable to participate in routine medical follow-up
On antiplatelet agents including clopidogrel, ticlopidine, prasugrel, and cangrelor. acetylsalicylic acid use will be allowed
On anticoagulants including heparin, warfarin, dabigatran, rivaroxaban, apixaban, and edoxaban

Where it is running

Johns Hopkins Medical Institutions — Baltimore, Maryland, United States

Full record on ClinicalTrials.gov

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