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

NCT03526263 | Completed DMC

• 1 other identifier: IRB00089675
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Gastric Mucosal Devitalization; Obesity; Endoscopic Bariatric Therapies; Bariatric surgery

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Submucosal injection volume

  6 months

• Energy settings

  6 months

Study Arms (1)

Gastric mucosal devitalization arm

EXPERIMENTAL

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

Interventions

Gastric mucosal devitalization PROCEDURE

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.

Gastric mucosal devitalization arm

Eligibility Criteria

• Age: 28 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

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

Sponsors & Collaborators

• Johns Hopkins University: lead
• Erbe USA Incorporated: collaborator

Study Sites (1)

Johns Hopkins Bayview Medical Center

Baltimore, Maryland, 21202, United States

Location

MeSH Terms

Conditions

Obesity; Obesity, Morbid

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Vivek Kumbhari, MD

  Johns Hopkins University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 16, 2018
• First Posted: May 16, 2018
• Study Start: June 7, 2018
• Primary Completion: November 29, 2018
• Study Completion: November 29, 2018
• Last Updated: September 24, 2019

Record last verified: 2019-09

Locations

US (1)