LAP-BAND Observational Cohort
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|ClinicalTrials.gov Identifier: NCT00283972|
Recruitment Status : Unknown
Verified January 2006 by Inamed.
Recruitment status was: Active, not recruiting
First Posted : January 31, 2006
Last Update Posted : January 31, 2006
|Condition or disease||Intervention/treatment||Phase|
|Epworth Sleepiness Scale Glycemic Control Liver Function Inflammation Iron and Bone Turnover SF-36 IW-QOL Lite HRQoL||Device: LAP-BAND System||Phase 4|
Study Type: Observational cohort. Single arm (non-comparative), non-randomized, multi-site surgical case series.
Objective: To prospectively observe the association of the LAP-BAND System device on measurements of quality of life, anthropometric, metabolic and biochemical parameters in morbidly obese patients when performed by experienced U.S. surgeons. Cost effectiveness analysis will also be done.
Numbers: This study will enroll 240 patients total from six U.S. bariatric surgical practices
Duration: Individual subject participation will be approximately 15 months. Data will be collected at a baseline less than three months prior to surgery or before starting a Very Low Calorie Diet (VLCD), then at 6 and 12 months post surgery. The total duration, including enrollment, of the observational period for the cohort is expected to be 21 months. Subjects have the option to consent for future contact by investigators for a period of 10 years following their surgery.
|Study Type :||Observational|
|Estimated Enrollment :||240 participants|
|Observational Model:||Defined Population|
|Observational Model:||Natural History|
|Official Title:||Health Outcome Study of LAP-BAND Adjustable Gastric Banding System|
|Study Start Date :||June 2005|
|Estimated Study Completion Date :||December 2006|
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): NCT00283972
|Study Chair:||Daniel Deykin, MD||Massachusetts Veterans Epidemiology Research adn Information Center|
|Principal Investigator:||Louis Fiore, MD||VA Office of Research and Development|