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

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

Detailed Description
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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.

Conditions
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Morbid Obesity

Intervention / Treatment
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* Device: LAP-BAND System


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 14 Years
Maximum Age: 17 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: LAP-BAND<br>All subjects who received the LAP-BAND System. | Device: LAP-BAND System<br>* Restriction of food intake<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percent of Subjects Who Attain Clinically Successful Weight Loss of ≥30% Excess Weight Loss (EWL) at 1 Year Post LAP-BAND Implantation. | Percent Excess Weight Loss was defined as Weight Loss divided by Excess Weight multiplied by 100. Excess Weight = baseline weight - ideal weight, where Ideal weight was determined using the 85th percentile on the Centers for Disease Control (CDC) Growth Charts for children and adolescents ages 2 to 20 years. | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Subject Excess Weight Loss Throughout the Study | Excess Weight Loss was examined over the 5 year period post LAP-BAND implantation. Excess Weight Loss was defined as Weight Loss divided by Excess Weight multiplied by 100. | Baseline to 5 Years | 
| Subject Percent Excess BMI Loss | Subject Percent Excess BMI Loss was examined at 5 years post LAP-BAND placement. | Baseline to 5 Years | 
| Change in Subjects' Comorbid Conditions | The change from baseline to year five in subjects' comorbid conditions of Type II Diabetes, Dyslipidemia, and Hypertension. Change as reported below indicates the condition resolved. | Baseline to 5 Years | 
| Change in Quality of Life Using the Beck Depression Inventory II (BDI) | Quality of life was examined using the Beck Depression Inventory II (BDI) questionnaire, which scores on a range from 0 (best) to 63 (worst). The change in subjects' BDI II score was assessed from baseline to 5 years. | Baseline to 5 Years | 
| Change in Quality of Life Using Impact of Weight on Quality of Life (IWQOL) Kids Questionnaire | Quality of life was examined using the Impact of Weight on Quality of Life (IWQOL) Kids questionnaire, which has a score range from 0(worst) to 100(best). The change in subjects' IWQOL Kids score was assessed from baseline to 5 years. | Baseline to 5 Years |