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Sponsors and Collaborators: |
New York University School of Medicine Hope Foundation |
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Information provided by: | New York University School of Medicine |
ClinicalTrials.gov Identifier: | NCT00587301 |
This study is to demonstrate the safety and efficacy of the use of the LAP-BAND surgery in the morbidly obese adolescent population.
Condition | Intervention | Phase |
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Obesity Adolescents DM |
Device: Lap-Band |
Phase II Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study |
Official Title: | A Prospective, Open-Label Study to Evaluate the Safety and Efficacy of Lap-Band® Adjustable Gastric Band (LAGB®) Operations in the Treatment of Morbidly Obese Adolescents (Ages 14-17) |
Enrollment: | 50 |
Study Start Date: | June 2005 |
Estimated Primary Completion Date: | December 2012 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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Lap-Band: Active Comparator
Lap-band surgery in treatment of morbidly obese adolescents
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Device: Lap-Band
Obesity and adolescents
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STUDY OBJECTIVES: Is to demonstrate the safety and efficacy of the use of the LAP-BAND® System in the morbidly obese adolescent population in the United States, and therefore provide these individuals with a significantly less morbid and reversible surgical option for weight loss.
STUDY VARIABLES:The primary efficacy variable is weight loss evaluated in terms of % excess weight loss (EWL).
DESIGN:Prospective, open-label, and single center
Ages Eligible for Study: | 14 Years to 17 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Responsible Party: | NYUSOM ( Christine Ren, M.D. ) |
Study ID Numbers: | H# 11876, G050010 |
Study First Received: | December 21, 2007 |
Last Updated: | December 21, 2007 |
ClinicalTrials.gov Identifier: | NCT00587301 History of Changes |
Health Authority: | United States: Food and Drug Administration; NYUSOM IBRA |
Child Obesity |
Body Weight Signs and Symptoms Obesity |
Nutrition Disorders Overweight Overnutrition |
Body Weight Signs and Symptoms Obesity |
Nutrition Disorders Overweight Overnutrition |