Effectiveness and Safety Study of LAP-BAND Treatment for Obese Adolescents
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|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||Phase|
|Morbid Obesity||Device: LAP-BAND System||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||153 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Study Start Date :||March 2007|
|Actual Primary Completion Date :||January 2009|
|Actual 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
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.|