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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
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Morbid Obesity Device: LAP-BAND System Not Applicable

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  (Clinical Trial)
Actual Enrollment : 153 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Study Start Date : March 2007
Actual Primary Completion Date : January 2009
Actual Study Completion Date : June 2013

Arm Intervention/treatment
Experimental: LAP-BAND
All subjects who received the LAP-BAND System.
Device: LAP-BAND System
Restriction of food intake




Primary Outcome Measures :
  1. 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.



Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.



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Ages Eligible for Study:   14 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

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


Locations
United States, Texas
Apollo Endosurgery
Austin, Texas, United States, 78746
Sponsors and Collaborators
Apollo Endosurgery, Inc.
Investigators
Study Director: Apollo Endosurgery Apollo Endosurgery, Inc.

Responsible Party: Apollo Endosurgery, Inc.
ClinicalTrials.gov Identifier: NCT00447590     History of Changes
Other Study ID Numbers: LBA-001
First Posted: March 15, 2007    Key Record Dates
Results First Posted: September 23, 2014
Last Update Posted: October 2, 2014
Last Verified: September 2014

Additional relevant MeSH terms:
Obesity, Morbid
Obesity
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms