Lap-Band Surgery on Adolescents for Safety and Efficacy (ALAGB)
This study is to demonstrate the safety and efficacy of the use of the LAP-BAND surgery in the morbidly obese adolescent population.
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|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)|
- To demonstrate the safety and efficacy of the use of the LAP-BAND® System in the morbidly obese adolescent population. [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]
- The secondary objective is to assess the status of co-morbidities and changes in quality of life from baseline. [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]
|Study Start Date:||June 2005|
|Estimated Study Completion Date:||December 2019|
|Estimated Primary Completion Date:||December 2018 (Final data collection date for primary outcome measure)|
Active Comparator: Lap-Band
Lap-band surgery in treatment of morbidly obese adolescents
Obesity and adolescents
Other Name: Lap-Band Adjustable Gastric Band (LAGB) Operation
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00587301
|Contact: Heekoung A Youn, M.A.||212 263 firstname.lastname@example.org|
|United States, New York|
|New York, New York, United States, 10016|
|Principal Investigator:||Christine Ren-Fielding, M.D.||NYUSOM|