Effectiveness and Safety Study of LAP-BAND Treatment for Obese Adolescents
- Conditions
- Morbid Obesity
- Interventions
- Device: LAP-BAND System
- Registration Number
- NCT00447590
- Lead Sponsor
- Apollo Endosurgery, Inc.
- Brief Summary
The purpose of this study is to determine whether the LAP-BAND system is safe and effective in morbidly obese adolescents.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 153
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description LAP-BAND LAP-BAND System All subjects who received the LAP-BAND System.
- Primary Outcome Measures
Name Time Method Percent of Subjects Who Attain Clinically Successful Weight Loss of ≥30% Excess Weight Loss (EWL) at 1 Year Post LAP-BAND Implantation. 1 year 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.
- Secondary Outcome Measures
Name Time Method Change in Subjects' Comorbid Conditions Baseline to 5 Years 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.
Change in Quality of Life Using the Beck Depression Inventory II (BDI) Baseline to 5 Years 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.
Subject Percent Excess BMI Loss Baseline to 5 Years Subject Percent Excess BMI Loss was examined at 5 years post LAP-BAND placement.
Subject Excess Weight Loss Throughout the Study Baseline to 5 Years 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.
Change in Quality of Life Using Impact of Weight on Quality of Life (IWQOL) Kids Questionnaire Baseline to 5 Years 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.
Trial Locations
- Locations (1)
Apollo Endosurgery
🇺🇸Austin, Texas, United States