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

Apollo Endosurgery

Status

Completed

Conditions

Morbid Obesity

Treatments

Device: LAP-BAND System

Study type

Interventional

Funder types

Industry

Identifiers

NCT00447590

LBA-001

Details and patient eligibility

About

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

Full 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.

Enrollment

153 patients

Sex

All

Ages

14 to 17 years old

Volunteers

No 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