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

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.

Study Overview

• Status: Completed
• Conditions: Obesity; Obesity, Morbid; Bariatric Surgery Candidate; Obesity; Endocrine
• Intervention / Treatment: Procedure: Gastric mucosal devitalization

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.

• Study Type: Interventional
• Enrollment (Actual): 6
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Maryland
    • Baltimore, Maryland, United States, 21202
      • Johns Hopkins Bayview Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 28 years to 60 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Patients scheduled to undergo vertical sleeve gastrectomy

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Gastric mucosal devitalization arm; Patients will be enrolled into the study after being scheduled to undergo vertical sleeve gastrectomy as part of routine clinical care at Johns Hopkins Bayview. The cost of the surgery will be covered by the patient's insurance and there will no extra procedural element that would add time to surgery. The intervention will occur on the excised specimen ex vivo (outside the body) and will involve devitalization of the gastric mucosa using Argon Plasma Coagulation.

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Selective mucosal devitalization color	Identify the optimal color of the tissue indicating that the gastric mucosa has been sufficiently treated such that selective mucosal devitalization has occurred (as determined by a pathologist examining the samples)	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Submucosal injection volume	Identify the optimal submucosal injection volume in milliliters required to facilitate selective mucosal devitalization (as determined by a pathologist examining the samples)	6 months
Energy settings	Identify the optimal energy settings of argon plasma coagulation required to facilitate selective mucosal devitalization (as determined by a pathologist examining the samples)	6 months

Collaborators and Investigators

• Sponsor: Johns Hopkins University
• Collaborators: Erbe USA Incorporated

Study record dates

Study Major Dates

• Study Start (Actual): June 7, 2018
• Primary Completion (Actual): November 29, 2018
• Study Completion (Actual): November 29, 2018

Study Registration Dates

• First Submitted: April 16, 2018
• First Submitted That Met QC Criteria: May 3, 2018
• First Posted (Actual): May 16, 2018

Study Record Updates

• Last Update Posted (Actual): September 24, 2019
• Last Update Submitted That Met QC Criteria: September 23, 2019
• Last Verified: September 1, 2019

More Information

Terms related to this study

• Keywords: Obesity; Bariatric surgery; Gastric Mucosal Devitalization; Endoscopic Bariatric Therapies
• Additional Relevant MeSH Terms: Overnutrition; Nutrition Disorders; Overweight; Body Weight; Obesity; Obesity, Morbid
• Other Study ID Numbers: IRB00089675

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No