Safety and Efficacy of Adjustable Gastric Band Operations for Patients With Body Mass Index (BMI) Between 30-40 kg/m2 (LBMI)

Inclusion Criteria:

• Be at least 18 and equal to or less than 60 years of age.
• BMI of at least 30 and maximum BMI of 40 with co-morbidities
• Willingness to comply with dietary restrictions required by the protocol
• History of obesity for at least 5 years
• History of at least 6 months of documented failures with traditional non-surgical weight loss methods
• Willingness to follow protocol requirements
• If female with childbearing potential, using an appropriate form of contraception

Exclusion Criteria:

• Age less than 18, age greater than 60
• Pregnancy
• History of major depressive disorder or psychosis
• Previous bariatric surgery or previous gastric surgery
• Presence of achalasia
• Presence of portal hypertension, cirrhosis, and/or varices
• Patient with inflammatory disease of the gastrointestinal tract such as Crohn's Disease
• Patients with autoimmune connective tissue disorders
• Patients with acute abdominal infections
• Any condition that, in the judgment of the investigator, would place a subject at undue risk, or potentially compromise the results or interpretation of the study