ESSENTIAL Trial™ Sham Cross-over

Inclusion Criteria

• Provide written informed consent.
• Potential subject was sham participant in the Essential pivotal trial
• Potential subject agrees to be compliant with study and has a documented history of compliance in pivotal study.
• Subjects between the ages of 23-61 years.
• If female, be either post-menopausal, surgically sterile or agree to practice birth control during year of study and have negative serum HCG at screening/baseline.
• Have a Body Mass Index (BMI) of ≥30 and 3 cm) by history or as determined by pre-enrollment endoscopy.
• Pancreatic insufficiency/disease.
• History of gastroparesis or symptoms that would be suggestive of gastroparesis.
• Pregnancy or plans of pregnancy in the next 12 months.
• Immunosuppressive medications or systemic steroids (i.e., oral prednisone) within 1 month of Visit 1. Intranasal/inhaled steroids are acceptable.
• History of inflammatory disease of the GI tract; coagulation disorders; hepatic insufficiency or cirrhosis
• History or present use of insulin or insulin derivatives for treatment of diabetes
• Type II Diabetes Mellitus (as defined by HgbA1c >6.5%) for greater than 11 years at the time of enrollment
• If smoker, plans to quit smoking in the year after enrollment
• Portal hypertension and/or varices.
• 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.
• Patient has a history of drug or alcohol abuse or positive at screening for drugs of abuse.
• Present or past history of psychosis, bipolar disease, or obsessive compulsive disorder after pre-enrollment history and medical /psychological assessment
• Non-ambulatory or has significant impairment of mobility.
• Known hormonal or genetic cause for obesity including untreated hypothyroidism (TSH >5.0 U/ml).
• Participating in another clinical study except for Essential Study.
• Subjects with a personal history of allergic/anaphylactic reactions including hypersensitivity to the drugs or materials that will be utilized in the study procedure.