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

Completed · Not applicable

Conditions studied: Morbid Obesity

In brief

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

Key facts

Study ID

NCT00447590

Run by

Apollo Endosurgery, Inc.

People needed

153

Starts

2007-03-01

Expected to finish

2013-06-01

Last updated by the study team

2014-10-02

Who can join

Age: 14 and older, up to 17. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Apollo Endosurgery — Austin, Texas, United States

Full record on ClinicalTrials.gov

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