Status:
COMPLETED
Effectiveness and Safety Study of LAP-BAND Treatment for Obese Adolescents
Lead Sponsor:
Apollo Endosurgery, Inc.
Conditions:
Morbid Obesity
Eligibility:
All Genders
14-17 years
Phase:
NA
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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
March 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2013
Estimated Enrollment :
153 Patients enrolled
Trial Details
Trial ID
NCT00447590
Start Date
March 1 2007
End Date
June 1 2013
Last Update
October 2 2014
Active Locations (1)
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1
Apollo Endosurgery
Austin, Texas, United States, 78746