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Sponsored by: |
University of Illinois |
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Information provided by: | University of Illinois |
ClinicalTrials.gov Identifier: | NCT00592202 |
The purpose of this study is to determine whether the LAP-BAND system is safe and effective in morbidly obese adolescents.
Condition | Intervention |
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Morbid Obesity in Adolescents Treatment |
Procedure: Placement of an adjustable gastric band |
Study Type: | Interventional |
Study Design: | Treatment, Open Label, Historical Control, Single Group Assignment, Safety/Efficacy Study |
Official Title: | Laparoscopic Adjustable Gastric Banding as a Treatment for Morbid Obesity in Adolescents |
Estimated Enrollment: | 50 |
Study Start Date: | December 2004 |
Estimated Study Completion Date: | June 2013 |
Estimated Primary Completion Date: | June 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental
Adolescents between the ages 14 through 17 with a BMI of 40 or more or with a BMI of 35 or more and with an obesity related comorbidity
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Procedure: Placement of an adjustable gastric band
Laparoscopic placement of an adjustable gastric band around the upper portion of the stomach and subsequent adjustments of the band via a subcutaneous port as needed to maintain appropriate restriction.
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Ages Eligible for Study: | 14 Years to 17 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Allen F. Browne F Browne, M.D. | 312-413-7707 | albrowne@uic.edu |
Contact: Mark Holterman, M.D. | 312-413-7707 |
United States, Illinois | |
UIMC | Recruiting |
Chicago, Illinois, United States, 60612 | |
Contact: Allen F Browne, M.D. 312-413-7707 albrowne@uic.edu | |
Contact: Mark Holterman, M.D. 312-413-7707 | |
Principal Investigator: Allen F Browne, M.D. |
Principal Investigator: | Allen F. Browne, M.D. | Division of Pediatric Surgery, UIC |
Responsible Party: | Division of Pediatric Surgery, UIC ( Allen F. Browne, M.D. ) |
Study ID Numbers: | 2004-0732 |
Study First Received: | December 27, 2007 |
Last Updated: | December 27, 2007 |
ClinicalTrials.gov Identifier: | NCT00592202 |
Health Authority: | United States: Food and Drug Administration |
Morbid obesity Adolescents Gastric restrictive procedure Adjustable gastric band |
Body Weight Signs and Symptoms Obesity Benzocaine |
Nutrition Disorders Overweight Overnutrition Obesity, Morbid |