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

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.

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