Endoscopic Suturing for Primary Obesity Treatment

Inclusion Criteria: * Subject has met diabetic lab testing and all pre-procedural qualifications * Subject is ≥ 18 yrs. of age and ≤ 60 yrs. of age * Subject has a BMI of \> 30 and \< 35 * Subject has history of obesity for \> 2 yrs * Subject has had no significant weight change (\<5% of total body weight)in last 6 months * Subject must have failed standard obesity therapy of diet, exercise, behavior modification, and pharmacologic agents either alone or in combination, as assessed by an interview with a member of the study team at baseline * Subject is a reasonable candidate for general anesthesia * Subject agrees not to have any additional weight loss surgery or reconstructive surgery that may affect body weight (i.e. mammoplasty, liposuction, lipoplasty, etc) during the trial * Subject must be willing and able to participate in all aspects of the study and agree to comply with all study requirements for the duration of the study. This includes availability of reliable transportation and sufficient time to attend all follow-up visits. * Subject must be able to fully understand and be willing to sign the informed consent Exclusion Criteria: * Subject has had significant weight loss in the last 3 months, or between baseline and the study procedure * Mallampati (intubation) score greater than 3 * Subject is observed during EGD to have heavily scarred, malignant or poor quality/friable tissue in areas of the stomach where sutures are to be placed * Subject has history or present use of insulin or insulin derivatives for treatment of diabetes * Subject has diabetes secondary to a specific disease * Subject has poorly controlled diabetes as indicated by the lack of stable diabetes medications and doses over the last month, or has a history of diabetes for greater than 10 years * Subject has history of inflammatory disease of GI tract * Subject has a history of intestinal strictures or adhesions * Subject has renal and/or hepatic insufficiency * Subject has chronic pancreatic disease * Subject has history of/or signs and/or symptoms of gastro-duodenal ulcer disease and/or active peptic ulcer * Subject has significant esophageal disease including Zenker's diverticulum, grade 3-4 reflux esophagitis, stricture, Barrett's esophagus, esophageal cancer, esophageal diverticulum, dysphagia, achalasia, or symptoms of dysmotility * Subject has a history of any significant abdominal surgery * Subject has had previous bariatric, gastric or esophageal surgery; intestinal obstruction; portal gastropathy; gastrointestinal tumors; esophageal or gastric varices, or gastroparesis * Subject has a hiatal hernia \> 2cm * Subject has chronic/acute upper GI bleeding conditions * Subject has severe coagulopathy (prothrombin time \> 3 seconds over control or platelet count \< 100,000) or is presently taking heparin, coumadin, warfarin, or other anticoagulants or other medications which impede coagulation or platelet aggregation * Female subject is of childbearing age and not practicing effective birth control, is pregnant or is lactating * Subject has symptomatic congestive heart failure, cardiac arrhythmia or unstable coronary artery disease. * Subject has cancer or life expectancy of \< 2 yrs * Subject has systemic infection in the body at the time of the plication procedure. * Subject currently uses or has used over the counter or prescription weight loss medications in last 30 days or intends to use during follow-up Study period. * Subjects who have started medications within the last 3 months that are known to cause weight gain * Subjects undergoing chronic steroid therapy * Subjects undergoing immunosuppressive therapy * Subject has a history of drug or alcohol abuse * Subject has a history of uncontrolled or poorly controlled psychiatric disease or suspected eating disorders * Subject is non-ambulatory or has significant impairment of mobility * Subject has known hormonal or genetic cause for obesity * Subject is not in sufficient and stable medical health, as determined and evaluated by the Principal Investigator. * Subject has participated in a clinical study with an investigational new drug, biological, or therapeutic device within ≤ 28 days prior to enrollment in this study, and does not agree to abstain from participation in other clinical trials of any kind during this study