Effectiveness and Safety Study of LAP-BAND Treatment for Obese Adolescents

The purpose of this study is to determine whether the LAP-BAND system is safe and effective in morbidly obese adolescents.

The primary objective of this study was to evaluate the safety and effectiveness of the LAP-BAND System in a morbidly obese adolescent population, ages 14 to 17 years. The secondary objectives were to assess associated changes from baseline in obesity-related comorbidities as well as psychosocial functioning.

Inclusion Criteria:

• Between the ages of 14 and 17 at the time of enrollment
• Have a BMI ≥ 40 kg/m2 (with or without obesity-related co-morbid conditions) or BMI ≥ 35 kg/m2 with one or more severe co-morbid conditions
• Have a history of obesity for at least 2 years and have failed more conservative weight-reduction alternatives, such as supervised diet, exercise and behavior modification programs

Exclusion Criteria:

• Family or subject history of congenital or acquired anomalies of the gastrointestinal tract
• Severe cardiopulmonary or other serious or uncontrolled organic disease
• Severe coagulopathy; hepatic insufficiency or cirrhosis
• History of bariatric, gastric, or esophageal surgery
• History of intestinal obstruction or adhesive peritonitis
• History of esophageal dysmotility disorders
• Type I diabetes