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

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 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.

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

Contacts and Locations

Study Locations

• United States
  • Maryland
    • Baltimore, Maryland, United States, 21287
      • Johns Hopkins Medical Institutions

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: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Gastric mucosal devitalization arm; Patients will be enrolled in the study after being scheduled to undergo vertical sleeve gastrectomy as part of routine clinical care, and the gastric mucosal devitalization procedure will be performed in-vivo utilizing Argon plasma coagulation three days before the operation.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pathological changes	Histopathological assessment to determine whether selective devitalization of mucosa and submucosa corresponds with decolorization during the in-vivo procedure.	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Technical feasibility	Feasibility of retroflexion technique during the in-vivo devitalization procedure assessed by the endoscopist.	6 months
Procedural tolerability	Tolerability of gastric mucosal devitalization after the post-procedural follow up assessed by the endoscopist	6 months

Collaborators and Investigators

• Sponsor: Johns Hopkins University
• Collaborators: Erbe USA Incorporated
• Investigators: Principal Investigator: Dilhana Badurdeen, MD, Johns Hopkins University

Study record dates

Study Major Dates

• Study Start (ACTUAL): September 25, 2020
• Primary Completion (ACTUAL): July 8, 2021
• Study Completion (ACTUAL): July 8, 2021

Study Registration Dates

• First Submitted: August 16, 2018
• First Submitted That Met QC Criteria: August 16, 2018
• First Posted (ACTUAL): August 20, 2018

Study Record Updates

• Last Update Posted (ACTUAL): July 20, 2021
• Last Update Submitted That Met QC Criteria: July 19, 2021
• Last Verified: July 1, 2021

More Information

Terms related to this study

• Keywords: obesity; metabolic syndrome; bariatric endoscopy; gastric mucosal devitalization; Endoscopic bariatric therapies
• Additional Relevant MeSH Terms: Overnutrition; Nutrition Disorders; Overweight; Body Weight; Obesity; Obesity, Morbid
• Other Study ID Numbers: IRB00089675-2

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No