Back to resultsEffectiveness and Safety Study of LAP-BAND Treatment for Obese Adolescents
Primary Purpose
Morbid Obesity
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
LAP-BAND System
Sponsored by
About this trial
This is an interventional treatment trial for Morbid Obesity
Eligibility Criteria
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
Sites / Locations
- Apollo Endosurgery
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
LAP-BAND
Arm Description
All subjects who received the LAP-BAND System.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
Subject Percent Excess BMI Loss
Subject Percent Excess BMI Loss was examined at 5 years post LAP-BAND placement.
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.
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.
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.
Full Information
NCT ID
NCT00447590
First Posted
March 14, 2007
Last Updated
September 22, 2014
Sponsor
Apollo Endosurgery, Inc.
1. Study Identification
Unique Protocol Identification Number
NCT00447590
Brief Title
Effectiveness and Safety Study of LAP-BAND Treatment for Obese Adolescents
Study Type
Interventional
2. Study Status
Record Verification Date
September 2014
Overall Recruitment Status
Completed
Study Start Date
March 2007 (undefined)
Primary Completion Date
January 2009 (Actual)
Study Completion Date
June 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Apollo Endosurgery, Inc.
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Morbid Obesity
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
153 (Actual)
8. Arms, Groups, and Interventions
Arm Title
LAP-BAND
Arm Type
Experimental
Arm Description
All subjects who received the LAP-BAND System.
Intervention Type
Device
Intervention Name(s)
LAP-BAND System
Intervention Description
Restriction of food intake
Primary Outcome Measure Information:
Title
Percent of Subjects Who Attain Clinically Successful Weight Loss of ≥30% Excess Weight Loss (EWL) at 1 Year Post LAP-BAND Implantation.
Description
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.
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Subject Excess Weight Loss Throughout the Study
Description
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.
Time Frame
Baseline to 5 Years
Title
Subject Percent Excess BMI Loss
Description
Subject Percent Excess BMI Loss was examined at 5 years post LAP-BAND placement.
Time Frame
Baseline to 5 Years
Title
Change in Subjects' Comorbid Conditions
Description
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.
Time Frame
Baseline to 5 Years
Title
Change in Quality of Life Using the Beck Depression Inventory II (BDI)
Description
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.
Time Frame
Baseline to 5 Years
Title
Change in Quality of Life Using Impact of Weight on Quality of Life (IWQOL) Kids Questionnaire
Description
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.
Time Frame
Baseline to 5 Years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
14 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Apollo Endosurgery
Organizational Affiliation
Apollo Endosurgery, Inc.
Official's Role
Study Director
Facility Information:
Facility Name
Apollo Endosurgery
City
Austin
State/Province
Texas
ZIP/Postal Code
78746
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Effectiveness and Safety Study of LAP-BAND Treatment for Obese Adolescents
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