Use of the Incisionless Operating Platform as a Primary Treatment for Obesity vs. Diet-Exercise Alone

Exclusion Criteria

• •History of (or intraoperative evidence of) bariatric, gastric or esophageal surgery
• •Esophageal stricture or other anatomy and/or condition that could preclude passage of endolumenal instruments
• •Severe gastroesophageal reflux disease (GERD), defined as symptoms that cause subject severe discomfort, compromise performance of daily activities, and/or condition is not entirely controlled with prescription drug therapy
• •Known hiatal hernia \>3 centimeters by history or as determined by Upper Gastrointestinal exam or endoscopy
• •Pancreatic insufficiency/disease
• •Active peptic ulcer
• •Pregnancy or plans of pregnancy in the next 12 months
• •Present Corticosteroid Use
• •History of inflammatory disease of Gastrointestinal \[GI\] tract; Coagulation disorders; hepatic insufficiency or cirrhosis
• •History or present use of insulin or insulin derivatives for treatment of diabetes
• •Type II Diabetes Mellitus \[DM\] (as defined by Glycosylated Hemoglobin \[HgbA1c\] \>6.5) for greater than 2 years at the time of enrollment
• •Uncontrolled Type II DM (HgbA1c \> 7.0 at screening)
• •Quit smoking within last 6 months at time of enrollment or plans to quit smoking in the next year
• •Immunosuppression
• •Portal hypertension and/or varices
• •Active gastric ulcer disease
• •Gastric outlet obstruction or stenosis
• •Beck Depression Inventory (Short) Score ≥12 (see Appendix IV);
• •Subject has a history of drug or alcohol abuse or actively abusing either as defined by Cage and DAST \[drug use\] questionnaires or positive Urinalysis \[UA\] drug screen
• •Severe disturbances in eating behavior (i.e. binge eating)
• •Known presence of a significant depression, psychosis, or other mood or eating disorder
• •Actively treated depression (except for stable treated depression for \>1year and normal \[Beck Depression Inventory \[BDI\] and psych exam)
• •Present or past history of psychosis or other mood or eating disorder
• •Non-ambulatory or has significant impairment of mobility
• •Known hormonal or genetic cause for obesity with the exception of treated hypothyroidism.
• •Participating in another clinical study
• •Is a first degree relative of investigator, or support staff involved in the study.
• •Employed by investigator or institution involved in the study
• •Subject is not able to provide written informed consent