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Sponsored by: |
Ethicon Endo-Surgery |
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Information provided by: | Ethicon Endo-Surgery |
ClinicalTrials.gov Identifier: | NCT00813462 |
To determine the re-operation rate (band revision, band replacement and explants resulting from serious adverse device-related event {SADE}) of gastric banding at 4 and 5 year post implant.
Condition | Intervention | Phase |
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Morbid Obesity |
Device: REALIZE™ Adjustable Gastric Band |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Open Label, Single Group Assignment, Safety Study |
Official Title: | 5 Year Post-Approval Study With the REALIZE™ Adjustable Gastric Band |
Estimated Enrollment: | 300 |
Study Start Date: | December 2008 |
Estimated Study Completion Date: | January 2014 |
Estimated Primary Completion Date: | December 2013 (Final data collection date for primary outcome measure) |
Ages Eligible for Study: | 18 Years to 60 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Subjects eligible to participate in this study must fulfill all of the following criteria:
Exclusion Criteria:
Presence of any of the following medical conditions;
United States, California | |
Sunil Bhoyrul, MD | Recruiting |
La Jolla, California, United States, 92037 | |
Contact: Simpson 858-452-5054 | |
United States, Florida | |
Robert T. Marema, MD | Recruiting |
St. Augustine, Florida, United States, 32086 | |
Contact: Marema 904-819-5861 |
Responsible Party: | Ethicon Endo-Surgery, Inc ( Sheryl Helsinger ) |
Study ID Numbers: | CI-07-0006 |
Study First Received: | December 22, 2008 |
Last Updated: | December 22, 2008 |
ClinicalTrials.gov Identifier: | NCT00813462 |
Health Authority: | United States: Institutional Review Board |
Body Weight Signs and Symptoms Obesity Nutrition Disorders |
Overweight Overnutrition Obesity, Morbid |