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Completed

NCT Number: NCT00447590

Effectiveness and Safety Study of LAP-BAND Treatment for Obese Adolescents

The purpose of this study is to determine whether the LAP-BAND system is safe and effective in morbidly obese adolescents.

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Key information

Conditions

Morbid Obesity Body Weight Nutrition Disorders Nutritional and Metabolic Diseases Obesity Obesity, Morbid Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

14 year–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Apollo Endosurgery

Austin, Texas, 78746, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

LAP-BAND System

Device

Restriction of food intake

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Apollo Endosurgery, Inc.

Industry

Registry information

Important dates

Study start
2007
Primary completion
2009
Study completion
2013
First posted
Mar 15, 2007
Registry last updated
Oct 2, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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