LAGB as a Treatment for Morbid Obesity in Adolescents
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|ClinicalTrials.gov Identifier: NCT01045499|
Recruitment Status : Completed
First Posted : January 11, 2010
Results First Posted : April 13, 2020
Last Update Posted : April 13, 2020
|Condition or disease||Intervention/treatment||Phase|
|Morbid Obesity Obstructive Sleep Apnea Syndrome Metabolic Syndrome Insulin Resistance Nonalcoholic Fatty Liver Disease||Device: Laparoscopic adjustable gastric banding (Allergan Lap Band)||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||137 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Laparoscopic Adjustable Gastric Banding (LAGB) as a Treatment for Morbid Obesity in Adolescents|
|Actual Study Start Date :||September 13, 2005|
|Actual Primary Completion Date :||July 31, 2016|
|Actual Study Completion Date :||April 30, 2017|
Experimental: laparoscopic gastric banding
Adolescent patients who have undergone laparoscopic adjustable gastric banding. Weight, BMI, and co-morbidity data will be compared to patient's pre-operative values.
Device: Laparoscopic adjustable gastric banding (Allergan Lap Band)
Pre-op evaluation, surgical placement of a gastric band, and follow-up for a minimum of 5 years after surgery. Surgery is laparoscopic adjustable gastric band placement using a single brand of gastric band. Evaluations before and after surgery include but are not limited to history and physical examination, serum chemistry studies, imaging, sleep studies, and pulmonary function testing.
Other Name: LAP-BAND®
- Percentage of Excess Weight Change (EWL) [ Time Frame: Baseline and up to 5 years from start of study. ]Weight change evaluated in terms of % excess weight loss (EWL).
- Percentage of Excess BMI Change [ Time Frame: Baseline and up to 5 years from start of study. ]Change in Body mass index (BMI) in terms of excess BMI loss (EBMIL).
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01045499
|United States, New York|
|Morgan Stanley Children's Hospital of NY Presbyterian|
|New York, New York, United States, 10032|
|Principal Investigator:||Jeffrey L Zitsman, MD||Columbia University|