Greater Curvature PlicationResolution of Comorbidities, Safety and Efficacy of Greater Curvature Plication in Obese Patients.

Inclusion Criteria:

1. Subject is willing to give consent and comply with evaluation and treatment schedule;
2. 18 to 65 years of age (inclusive);
3. Have a BMI > 27 with one or more significant co-morbid medical conditions which are generally expected to be improved, reversed, or resolved by weight loss. These conditions may include but are not be limited to -

• Hyperlipidemia
• Type 2 diabetes
• Mild obstructive sleep apnea
• Hypertension
• Osteoarthritis of the hip or knee

4. Agree to refrain from any type of weight-loss drug (prescription or OTC) or elective procedure that would affect body weight for the duration of the trial;
5. HbA1C < 11%
6. For subjects who have Type 2 diabetes, the anti-diabetic medication regimen is no more complex than oral metformin plus one oral sulfonylurea plus once daily insulin injection.
7. Ability to self pay for the procedure and follow up.

Exclusion Criteria:

1. Previous malabsorptive or restrictive procedures performed for the treatment of obesity;
2. Scheduled concurrent surgical procedure, with the exception of SOC liver biopsy;
3. Women of childbearing potential who are pregnant or lactating at the time of screening or at the time of surgery;
4. Any condition which precludes compliance with the study;
5. History or presence of pre-existing autoimmune connective tissue disease
6. Use of prescription or over the counter weight reduction medications or supplements within thirty days of the Screening Visit or the duration of study participation.
7. Psychiatric disorders that may affect compliance with the clinical trial, including dementia, active psychosis, severe depression requiring > 2 medications, or history of suicide attempts. Any condition which places the subject at undue risk for the procedure (surgeon's discretion).