FDA indicated study should have had prior IDE submission & approval

The primary objective is to collect data on the use of the EndoSurgical Operating System (EOS) for gastric tissue approximation during primary gastric restrictive procedures.

Inclusion Criteria:

• Patient has met diabetic lab testing and all pre-procedural qualifications as delineated below.
• Patient is >/= 20 yrs. of age and </= 60 yrs. of age
• Patient has a BMI of >/=30 and < 40
• Patient has history of obesity for >/= 2 yrs.
• Patient has had not significant weight change (<5% of total body weight) in last 6 months.
• Patient is a reasonable candidate for general anesthesia
• Patient agrees not to have any additional weight loss surgery or liposuction for 2 yrs. following procedure.

Exclusion Criteria:

• Patient is not able and willing to return for all follow-up evaluations, tests and nutritional counseling.
• Patient is not able to provide written informed consent
• Patient has history or present use of insulin or insulin derivatives for treatment of diabetes.
• Patient has diabetes secondary to a specific disease.
• Patient has history of inflammatory disease of GI tract
• Patient has diabetic retinopathy
• Patient has chronic pancreatic disease
• Patient ahs active peptic ulcer
• Patient has portal hypertension
• Patient has esophageal varices
• Patient has significant esophageal disease
• Patient has a history of any significant abdominal surgery
• Patient has a history of any bariatric or GERD surgical procedures
• Patient has a hiatal hernia > 2cm.
• Patient has esophageal stricture or other anatomy and/or condition that could preclude passage of endolumenal instruments
• Patient is of childbearing age and not practicing effective birth control method, pregnant or lactating.
• Patient has had a MI or CVA in last year, or has unstable cardiovascular disease.
• Patient has cancer or life expectancy of < 2 yrs.
• Patient currently uses or has used over the counter or prescription weight loss drugs in last month or intends to use during follow-up Registry period.
• Patient has quit smoking within last 6 months or plans to quit smoking in the next year.
• Patient has a history of durg or alcohol abuse
• Patient has uncontrolled depression, psychosis, or eating disorder.
• Patient is non-ambulatory or has significant impairment of mobility.
• Patient has known hormonal or genetic cause for obesity.
• Patient is participating in another Registry and/or Study that could adversely affect this Registry.