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

Primary Purpose

Obesity, Obesity, Morbid, Obesity; Endocrine

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Gastric mucosal devitalization
Sponsored by
Johns Hopkins University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Obesity focused on measuring bariatric endoscopy, obesity, metabolic syndrome, gastric mucosal devitalization, Endoscopic bariatric therapies

Eligibility Criteria

28 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Johns Hopkins Medical Institutions

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Gastric mucosal devitalization arm

Arm Description

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.

Outcomes

Primary Outcome Measures

Pathological changes
Histopathological assessment to determine whether selective devitalization of mucosa and submucosa corresponds with decolorization during the in-vivo procedure.

Secondary Outcome Measures

Technical feasibility
Feasibility of retroflexion technique during the in-vivo devitalization procedure assessed by the endoscopist.
Procedural tolerability
Tolerability of gastric mucosal devitalization after the post-procedural follow up assessed by the endoscopist

Full Information

First Posted
August 16, 2018
Last Updated
July 19, 2021
Sponsor
Johns Hopkins University
Collaborators
Erbe USA Incorporated
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1. Study Identification

Unique Protocol Identification Number
NCT03638843
Brief Title
Endoscopic Gastric Mucosal Devitalization (GMD) as a Primary Obesity Therapy - Part 2
Official Title
Endoscopic Gastric Mucosal Devitalization (GMD) as a Primary Obesity Therapy - Part 2
Study Type
Interventional

2. Study Status

Record Verification Date
July 2021
Overall Recruitment Status
Completed
Study Start Date
September 25, 2020 (Actual)
Primary Completion Date
July 8, 2021 (Actual)
Study Completion Date
July 8, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Johns Hopkins University
Collaborators
Erbe USA Incorporated

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity, Obesity, Morbid, Obesity; Endocrine, Bariatric Surgery Candidate
Keywords
bariatric endoscopy, obesity, metabolic syndrome, gastric mucosal devitalization, Endoscopic bariatric therapies

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
6 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Gastric mucosal devitalization arm
Arm Type
Experimental
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
Gastric mucosal devitalization
Intervention Description
Gastric mucosal devitalization is an endoscopic procedure which uses argon plasma coagulation to result in selective damage to the gastric mucosa and submucosa.
Primary Outcome Measure Information:
Title
Pathological changes
Description
Histopathological assessment to determine whether selective devitalization of mucosa and submucosa corresponds with decolorization during the in-vivo procedure.
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Technical feasibility
Description
Feasibility of retroflexion technique during the in-vivo devitalization procedure assessed by the endoscopist.
Time Frame
6 months
Title
Procedural tolerability
Description
Tolerability of gastric mucosal devitalization after the post-procedural follow up assessed by the endoscopist
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
28 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dilhana Badurdeen, MD
Organizational Affiliation
Johns Hopkins University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Johns Hopkins Medical Institutions
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21287
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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