Endoscopic Gastric Mucosal Ablation as a Primary Obesity Therapy

Inclusion Criteria:

1. Male or females patients in the range of class I to class III obesity (BMI ≥ 30 to ≤ 40 with obesity-related comorbidity or BMI > 40 to BMI ≤ 45).

2. Age 22 - 60 yrs.

3. Treatment naïve for bariatric surgery or endoscopic bariatric therapy

4. Agree to avoid any use of weight loss medications such as Meridia, Saxenda, Januvia,Xenical, Duromine or over the counter weight loss medications or supplementsthroughout the study.

5. Women of childbearing potential (WOCBP) must agree to use acceptable contraceptionmethods.

6. Agree not to donate blood during their participation in the study.

7. Able to comply with study requirements and understand and sign the Informed ConsentForm.

8. Stable weight defined as a fluctuation of less than 5% for at least 3 months priorto screening visit.

9. History of failure to lose weight using conventional diet and lifestyle therapies.

Exclusion Criteria:

1. Patients requiring exogenous insulin.

2. HbA1c > 8.5 %

3. Pregnant or breast-feeding or intending to get pregnant during the study.

4. Unwilling or unable to complete the Visual Analogue Scale for pain assessment,patient questionnaires, or comply with study visits and other study procedures asrequired per protocol.

5. History of diabetic ketoacidosis or hyperosmolar nonketotic coma.

6. Probable insulin production failure, defined as fasting C-Peptide serum < 1 ng/mL (333 pmol/l).

7. Previous use of any types of insulin for > 1 month (at any time, except fortreatment of gestational diabetes).

8. Change in diabetic treatment within the last three months.

9. Use of glucose-lowering drugs for diabetes mellitus treatment with the exception ofsulfonylurea (SU), biguanides and sodium dependent glucose co-transporter 2 (SGLT-2)inhibitors.

10. Change of diabetes medication or doses 12 weeks prior to screening visit.

11. Hypoglycemia unawareness or a history of severe hypoglycemia (more than 1 severehypoglycemic event, as defined by need for third-party-assistance, in the lastyear).

12. Known autoimmune disease, including but not limited to celiac disease, orpre-existing symptoms of systemic lupus erythematosus, scleroderma or otherautoimmune connective tissue disorder.

13. Previous upper GI surgery, or other endoscopic bariatric procedures or conditions,prior intra-gastric balloon or another gastric implant.

14. History of diabetic gastroparesis.

15. Known active hepatitis or active liver disease.

16. Acute gastrointestinal illness in the previous 7 days.

17. Known history irritable bowel syndrome, radiation enteritis or other inflammatorybowel disease, such as Crohn's disease.

18. Known history of a structural or functional disorder of the esophagus that mayimpede passage of the device through the gastrointestinal tract or increase risk ofesophageal damage during an endoscopic procedure, including Barrett's esophagus,esophagitis, dysphagia, achalasia, stricture/stenosis, esophageal varices,esophageal diverticula, esophageal perforation, or any other disorder of theesophagus.

19. Known history of a structural or functional disorder of the esophagus, including anyswallowing disorder, esophageal chest pain disorders, or drug refractory esophagealreflux symptoms.

20. Known history of a structural or functional disorder of the stomach includinggastroparesis, gastric ulcer, chronic gastritis, gastric varices, hiatal hernia (>3cm), cancer or any other disorder of the stomach.

21. Known history of chronic symptoms suggestive of a structural or functional disorderof the stomach, including any symptoms of chronic upper abdominal pain, chronicnausea, chronic vomiting, chronic dyspepsia or symptoms suggestive of gastroparesis,including post-prandial fullness or pain, post-prandial nausea or vomiting or earlysatiety.

22. Currently have ongoing symptoms suggestive of intermittent small bowel obstruction,such as recurrent bouts of post-prandial abdominal pain, nausea or vomiting.

23. Active H. pylori infection (Subjects with active H. pylori may continue with thescreening process if they are treated with an appropriate antibiotic regimen, anderadication has been confirmed).

24. History of coagulopathy, upper gastrointestinal bleeding conditions such as ulcers,gastric varices, strictures, congenital or acquired intestinal telangiectasia.

25. Current use of anticoagulation therapy

26. Obligate use of anti-inflammatory drugs that cannot be suspended for a minimum of 4weeks post procedure

27. Use of systemic glucocorticoids (excluding topical or ophthalmic application orinhaled forms) for more than 10 consecutive days within 90 days prior to theScreening Visit.

28. Use of drugs known to affect GI motility (e.g. Metoclopramide).

29. Receiving any weight loss medications such as Meridia, Xenical, Saxenda, Januvia,Duromine or over the counter weight loss medications at screening.

30. Untreated/inadequately treated hypothyroidism, defined as an elevatedThyroid-Stimulating Hormone (TSH) level at Screening; if on thyroid hormonereplacement therapy, must be on stable dose for at least 6 weeks prior to Screening.

31. Persistent Anemia, defined as Hemoglobin <10 g/dL.

32. Significant cardiovascular disease including known history of valvular disease, ormyocardial infarction, heart failure, transient ischemic attack or stroke within thelast 6 months.

33. Known moderate or severe chronic kidney disease (CKD), with estimated glomerularfiltration rate (eGFR) <45 ml/min/1.73m2 (estimated by MDRD).

34. Known immunocompromised status, including but not limited to individuals who haveundergone organ transplantation, chemotherapy or radiotherapy within the past 12months, who have clinically-significant leukopenia, who are positive for the humanimmunodeficiency virus (HIV) or whose immune status makes the subject a poorcandidate for clinical trial participation in the opinion of the Investigator.

35. Active systemic infection.

36. Known active malignancy within the last 5 years (with the exception of treated basalcell or treated squamous cell carcinoma).

37. Subjects with an established diagnosis of Multiple Endocrine Neoplasia syndrome type

39. Not a candidate for surgery or general anesthesia.

40. Active illicit substance abuse or alcoholism.

41. Current smoker or smoking history in the last six months.

42. Participating in another ongoing clinical trial of an investigational drug ordevice.

43. Any other mental or physical condition which, in the opinion of the investigator,makes the subject a poor candidate for clinical trial participation.

44. Other medical condition that does not allow for endoscopic procedure.