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

Morbid Obesity Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00447590
• Other study ID #: LBA-001
• Status: Completed
• Phase: N/A
• First received: March 14, 2007
• Last updated: September 22, 2014
• Start date: March 2007
• Est. completion date: June 2013

Study information

• Verified date: September 2014
• Source: Apollo Endosurgery, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 153
• Est. completion date: June 2013
• Est. primary completion date: January 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 14 Years to 17 Years

Eligibility

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 Design

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

Related Conditions & MeSH terms

• Morbid Obesity
• Obesity, Morbid

Intervention

Device:
• LAP-BAND System
Restriction of food intake

Locations

Country	Name	City	State
United States	Apollo Endosurgery	Austin	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Apollo Endosurgery, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	1 year	No
Secondary	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.	Baseline to 5 Years	No
Secondary	Subject Percent Excess BMI Loss	Subject Percent Excess BMI Loss was examined at 5 years post LAP-BAND placement.	Baseline to 5 Years	No
Secondary	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.	Baseline to 5 Years	No
Secondary	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.	Baseline to 5 Years	No
Secondary	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.	Baseline to 5 Years	No