Effectiveness and Safety Study of LAP-BAND Treatment for Obese Adolescents
|ClinicalTrials.gov Identifier: NCT00447590|
Recruitment Status : Completed
First Posted : March 15, 2007
Results First Posted : September 23, 2014
Last Update Posted : October 2, 2014
|Condition or disease||Intervention/treatment|
|Morbid Obesity||Device: LAP-BAND System|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||153 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Study Start Date :||March 2007|
|Primary Completion Date :||January 2009|
|Study Completion Date :||June 2013|
All subjects who received the LAP-BAND System.
Device: LAP-BAND System
Restriction of food intake
- Percent of Subjects Who Attain Clinically Successful Weight Loss of ≥30% Excess Weight Loss (EWL) at 1 Year Post LAP-BAND Implantation. [ Time Frame: 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.
- Subject Excess Weight Loss Throughout the Study [ Time Frame: 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.
- Subject Percent Excess BMI Loss [ Time Frame: Baseline to 5 Years ]Subject Percent Excess BMI Loss was examined at 5 years post LAP-BAND placement.
- Change in Subjects' Comorbid Conditions [ Time Frame: 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) [ Time Frame: 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.
- Change in Quality of Life Using Impact of Weight on Quality of Life (IWQOL) Kids Questionnaire [ Time Frame: 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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00447590
|United States, Texas|
|Austin, Texas, United States, 78746|
|Study Director:||Apollo Endosurgery||Apollo Endosurgery, Inc.|