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

Apollo Endosurgery, Inc.153 enrolled

Overview

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

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

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

153

Conditions

Morbid Obesity

Interventions

LAP-BAND SystemDEVICE

Restriction of food intake

Eligibility

Sex: ALLMin age: 14 YearsMax age: 17 Years

Medical Language ↔ Plain English

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

Locations (1)

Apollo Endosurgery

Austin, Texas, United States

Outcomes

Primary Outcomes

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.

Time frame: 1 year

Secondary Outcomes

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.

Time frame: Baseline to 5 Years

Subject Percent Excess BMI Loss

Subject Percent Excess BMI Loss was examined at 5 years post LAP-BAND placement.

Time frame: Baseline to 5 Years

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.

Time frame: Baseline to 5 Years

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.

Time frame: Baseline to 5 Years

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.

Data from ClinicalTrials.gov

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