This study is to demonstrate the safety and efficacy of the use of the LAP-BAND surgery in the morbidly obese adolescent population.
STUDY OBJECTIVES: Is to demonstrate the safety and efficacy of the use of the LAP-BAND® System in the morbidly obese adolescent population in the United States, and therefore provide these individuals with a significantly less morbid and reversible surgical option for weight loss. STUDY VARIABLES:The primary efficacy variable is weight loss evaluated in terms of % excess weight loss (EWL). DESIGN:Prospective, open-label, and single center
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
119
Obesity and adolescents
New York University School of Medicine
New York, New York, United States
Percentage of Excess Weight Loss (EWL)
Time frame: Year 1
Percentage of Excess Weight Loss (EWL)
Time frame: Year 2
Percentage of Excess Weight Loss (EWL)
Time frame: Year 3
Percentage of Excess Weight Loss (EWL)
Time frame: Year 4
Percentage of Excess Weight Loss (EWL)
Time frame: Year 5
Body Mass Index (BMI)
Time frame: Year 1
Body Mass Index (BMI)
Time frame: Year 2
Body Mass Index (BMI)
Time frame: Year 3
Body Mass Index (BMI)
Time frame: Year 4
Body Mass Index (BMI)
Time frame: Year 5
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