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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00447590

Enrollment

153

Registered

2007-03-15

Start date

2007-03-31

Completion date

2013-06-30

Last updated

2014-10-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Morbid Obesity

Brief summary

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

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.

Interventions

DEVICELAP-BAND System

Restriction of food intake

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

14 Years to 17 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Percent of Subjects Who Attain Clinically Successful Weight Loss of ≥30% Excess Weight Loss (EWL) at 1 Year Post LAP-BAND Implantation.	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

Measure	Time frame	Description
Subject Excess Weight Loss Throughout the Study	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.
Subject Percent Excess BMI Loss	Baseline to 5 Years	Subject Percent Excess BMI Loss was examined at 5 years post LAP-BAND placement.
Change in Subjects' Comorbid Conditions	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.
Change in Quality of Life Using the Beck Depression Inventory II (BDI)	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.
Change in Quality of Life Using Impact of Weight on Quality of Life (IWQOL) Kids Questionnaire	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.

Countries

United States

Participant flow

Pre-assignment details

174 participants were enrolled in the study, where enrollment was defined as signing the informed consent form. 21 participants were not implanted after signing the informed consent. 153 participants were treated with the LAP-BAND.

Participants by arm

Arm	Count
LAP-BAND All subjects who received the LAP-BAND System.	153
Total	153

Withdrawals & dropouts

Period	Reason	FG000
Overall Study	Band Removed/Eroded/Other Follow-Up Loss	10
Overall Study	Lost to Follow-up	24
Overall Study	Withdrawal by Subject	26

Baseline characteristics

Characteristic	LAP-BAND
Age, Continuous	15.8 years
Age, Customized Age 14	25 participants
Age, Customized Age 15	33 participants
Age, Customized Age 16	47 participants
Age, Customized Age 17	46 participants
Age, Customized Age 18	2 participants
Body Mass Index (BMI)	48.5 kg/m2
Excess Weight	152.3 pounds (lb)
Race/Ethnicity, Customized Black/African-American	37 participants
Race/Ethnicity, Customized Caucasian	102 participants
Race/Ethnicity, Customized Hispanic/Latino	10 participants
Race/Ethnicity, Customized Other	4 participants
Sex: Female, Male Female	103 Participants
Sex: Female, Male Male	50 Participants

Adverse events

Event type	EG000 affected / at risk
deaths Total, all-cause mortality	— / —
other Total, other adverse events	133 / 153
serious Total, serious adverse events	20 / 153

Outcome results

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.

Time frame: 1 year

Population: Intent to treat (ITT) population with imputation at month 12 (ITT population consisted of participants treated with the LAP-BAND).

Arm	Measure	Value (NUMBER)
LAP-BAND	Percent of Subjects Who Attain Clinically Successful Weight Loss of ≥30% Excess Weight Loss (EWL) at 1 Year Post LAP-BAND Implantation.	49.7 percentage of participants

Comparison: p-Value is from a 2-sided exact binomial test to test the null hypothesis that 30% of subjects have at least 30% EWL.p-value: <0.00012-sided Exact Binomial Test

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.