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

Primary Purpose

Obesity, Obesity, Morbid, Obesity; Endocrine

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Gastric mucosal devitalization

About this trial

This is an interventional treatment trial for Obesity focused on measuring Gastric Mucosal Devitalization, Obesity, Endoscopic Bariatric Therapies, Bariatric surgery

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 Bayview Medical Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Gastric mucosal devitalization arm

Arm Description

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.

Outcomes

Primary Outcome Measures

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)

Secondary Outcome Measures

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)

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)

Full Information

NCT ID

NCT03526263

First Posted

April 16, 2018

Last Updated

September 23, 2019

Sponsor

Johns Hopkins University

Collaborators

Erbe USA Incorporated

1. Study Identification

Unique Protocol Identification Number

NCT03526263

Brief Title

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

Acronym

GMD

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

September 2019

Overall Recruitment Status

Completed

Study Start Date

June 7, 2018 (Actual)

Primary Completion Date

November 29, 2018 (Actual)

Study Completion Date

November 29, 2018 (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

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

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 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.

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

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

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

Intervention Type

Procedure

Intervention Name(s)

Gastric mucosal devitalization

Intervention Description

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.

Primary Outcome Measure Information:

Title

Selective mucosal devitalization color

Description

Time Frame

6 months

Secondary Outcome Measure Information:

Title

Submucosal injection volume

Description

Identify the optimal submucosal injection volume in milliliters required to facilitate selective mucosal devitalization (as determined by a pathologist examining the samples)

Time Frame

6 months

Title

Energy settings

Description

Identify the optimal energy settings of argon plasma coagulation required to facilitate selective mucosal devitalization (as determined by a pathologist examining the samples)

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

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

Vivek Kumbhari, MD

Organizational Affiliation

Johns Hopkins University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Johns Hopkins Bayview Medical Center

City

Baltimore

State/Province

Maryland

ZIP/Postal Code

21202

Country

United States

12. IPD Sharing Statement

Learn more about this trial

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

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