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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Apollo Endosurgery, Inc.
ClinicalTrials.gov Identifier:
NCT00447590
First received: March 14, 2007
Last updated: September 22, 2014
Last verified: September 2014
  Purpose

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


Condition Intervention
Morbid Obesity
Device: LAP-BAND System

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by Apollo Endosurgery, Inc.:

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. [ Time Frame: 1 year ] [ Designated as safety issue: No ]

    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 [ Time Frame: Baseline to 5 Years ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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.


Enrollment: 153
Study Start Date: March 2007
Study Completion Date: June 2013
Primary Completion Date: January 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: LAP-BAND
All subjects who received the LAP-BAND System.
Device: LAP-BAND System
Restriction of food intake

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.

  Eligibility

Ages Eligible for Study:   14 Years to 17 Years
Genders Eligible for Study:   Both
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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.
  More Information

No publications provided

Responsible Party: Apollo Endosurgery, Inc.
ClinicalTrials.gov Identifier: NCT00447590     History of Changes
Other Study ID Numbers: LBA-001
Study First Received: March 14, 2007
Results First Received: September 16, 2014
Last Updated: September 22, 2014
Health Authority: United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on November 24, 2014