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

Sponsor

Johns Hopkins University (Other)

Overall Status

Completed

CT.gov ID

NCT03526263

Collaborator

Erbe USA Incorporated (Other)

Enrollment

Location

Arm

5.7

Actual Duration (Months)

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Obesity Obesity, Morbid Obesity; Endocrine Bariatric Surgery Candidate	Procedure: Gastric mucosal devitalization	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

6 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Jun 7, 2018

Actual Primary Completion Date :

Nov 29, 2018

Actual Study Completion Date :

Nov 29, 2018

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

Selective mucosal devitalization color [6 months]
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 [6 months]
Identify the optimal submucosal injection volume in milliliters required to facilitate selective mucosal devitalization (as determined by a pathologist examining the samples)
Energy settings [6 months]
Identify the optimal energy settings of argon plasma coagulation required to facilitate selective mucosal devitalization (as determined by a pathologist examining the samples)

Eligibility Criteria

Criteria

Ages Eligible for Study:

28 Years to 60 Years

Sexes Eligible for Study:

All

Accepts 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