ESSENTIAL Trial™ Sham Cross-over

Exclusion Criteria

• •1. History of (or intra-operative evidence of) prior bariatric, gastric or esophageal surgery.
• •2. Esophageal stricture or other anatomy and/or condition that could preclude passage of endolumenal instruments or procedure execution.
• •3. Severe gastro-esophageal reflux disease (GERD), defined as symptoms that cause subject severe discomfort, compromise performance of daily activities, and/or condition is not entirely controlled with drug therapy.
• •4. Large hiatal hernia (\>3 cm) by history or as determined by pre-enrollment endoscopy.
• •5. Pancreatic insufficiency/disease.
• •6. History of gastroparesis or symptoms that would be suggestive of gastroparesis.
• •7. Pregnancy or plans of pregnancy in the next 12 months.
• •8. Immunosuppressive medications or systemic steroids (i.e., oral prednisone) within 1 month of Visit 1. Intranasal/inhaled steroids are acceptable.
• •9. History of inflammatory disease of the GI tract; coagulation disorders; hepatic insufficiency or cirrhosis
• •10. History or present use of insulin or insulin derivatives for treatment of diabetes
• •11. Type II Diabetes Mellitus (as defined by HgbA1c \>6.5%) for greater than 11 years at the time of enrollment
• •12. If smoker, plans to quit smoking in the year after enrollment
• •13. Portal hypertension and/or varices.
• •14. Significant abnormality identified during Visit 2 (enrollment visit) with endoscopy revealing large hiatal hernia, gastric/duodenal ulcer, gastric erosions, gastric outlet obstruction or stenosis, etc.
• •15. Patient has a history of drug or alcohol abuse or positive at screening for drugs of abuse.
• •16. Present or past history of psychosis, bipolar disease, or obsessive compulsive disorder after pre-enrollment history and medical /psychological assessment
• •17. Non-ambulatory or has significant impairment of mobility.
• •18. Known hormonal or genetic cause for obesity including untreated hypothyroidism (TSH \>5.0 U/ml).
• •19. Participating in another clinical study except for Essential Study.
• •20. Subjects with a personal history of allergic/anaphylactic reactions including hypersensitivity to the drugs or materials that will be utilized in the study procedure.