Effectiveness and Safety Study of LAP-BAND Treatment for Obese Adolescents
September 22, 2014 updated by: Apollo Endosurgery, Inc.
The purpose of this study is to determine whether the LAP-BAND system is safe and effective in morbidly obese adolescents.
Study Overview
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.
Study Type
Interventional
Enrollment (Actual)
153
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Texas
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Austin, Texas, United States, 78746
- Apollo Endosurgery
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
14 years to 17 years (Child)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: LAP-BAND
All subjects who received the LAP-BAND System.
|
Restriction of food intake
|
What is the study measuring?
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.
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. |
1 year
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
Baseline to 5 Years
|
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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.
|
Baseline to 5 Years
|
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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.
|
Baseline to 5 Years
|
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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.
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Baseline to 5 Years
|
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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.
|
Baseline to 5 Years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Apollo Endosurgery, Apollo Endosurgery, Inc.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
March 1, 2007
Primary Completion (Actual)
January 1, 2009
Study Completion (Actual)
June 1, 2013
Study Registration Dates
First Submitted
March 14, 2007
First Submitted That Met QC Criteria
March 14, 2007
First Posted (Estimate)
March 15, 2007
Study Record Updates
Last Update Posted (Estimate)
October 2, 2014
Last Update Submitted That Met QC Criteria
September 22, 2014
Last Verified
September 1, 2014
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- LBA-001
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.