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

This study is ongoing, but not recruiting participants.

Sponsored by:	Allergan Medical
Information provided by:	Allergan Medical
ClinicalTrials.gov Identifier:	NCT00447590

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

MedlinePlus related topics: Obesity Obesity in Children

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study

Further study details as provided by Allergan Medical:

Primary Outcome Measures:

Percent of subjects who attain clinically successful weight loss at one year post LAP-BAND implantation. [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	150
Study Start Date:	February 2006
Estimated Study Completion Date:	February 2016
Estimated Primary Completion Date:	February 2016 (Final data collection date for primary outcome measure)

Intervention Details:

Restriction of food intake

Eligibility

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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00447590

Locations

United States, Illinois

Chicago, Illinois, United States

Sponsors and Collaborators

Allergan Medical

Investigators

Study Director:

Allergan Medical

More Information

Responsible Party:	Allergan Medical ( Medical Officer )
Study ID Numbers:	LBA-001
Study First Received:	March 14, 2007
Last Updated:	June 16, 2008
ClinicalTrials.gov Identifier:	NCT00447590
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Body Weight
Signs and Symptoms
Obesity
Nutrition Disorders

Overweight
Overnutrition
Obesity, Morbid

ClinicalTrials.gov processed this record on January 16, 2009