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| Sponsor: | New York University School of Medicine |
|---|---|
| Collaborator: |
Hope Foundation |
| Information provided by: | New York University School of Medicine |
| ClinicalTrials.gov Identifier: | NCT00587301 |
Purpose
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 |
|---|---|---|
|
Obesity DM |
Device: Lap-Band |
Phase II Phase III |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized 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) |
| Estimated Enrollment: | 100 |
| Study Start Date: | June 2005 |
| Estimated Study Completion Date: | December 2016 |
| Estimated Primary Completion Date: | December 2015 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: Lap-Band
Lap-band surgery in treatment of morbidly obese adolescents
|
Device: Lap-Band
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
Eligibility| Ages Eligible for Study: | 14 Years to 17 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Express willingness to follow protocol requirements.
•Assure investigators that subject, if female of childbearing potential, is using an appropriate form of contraception.
Exclusion Criteria:
Contacts and Locations| Contact: Heekoung A Youn, M.A. | 212 263 3166 | heekoung.youn@med.nyu.edu |
| United States, New York | |
| NYU SOM | Recruiting |
| New York, New York, United States, 10016 | |
| Principal Investigator: | Christine Ren, M.D. | NYUSOM |
More Information
| Responsible Party: | Christine Ren, M.D., NYUSOM |
| ClinicalTrials.gov Identifier: | NCT00587301 History of Changes |
| Other Study ID Numbers: | H# 11876, G050010 |
| Study First Received: | December 21, 2007 |
| Last Updated: | July 12, 2011 |
| Health Authority: | United States: Food and Drug Administration; United States: NYUSOM IBRA |
|
Child Obesity |
|
Obesity Overnutrition Nutrition Disorders |
Overweight Body Weight Signs and Symptoms |