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U.S. Department of Health and Human Services

Post-Approval Studies (PAS)

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The FDA has the authority to require sponsors to perform a post-approval study (or studies) at the time of approval of a premarket approval (PMA), humanitarian device exemption (HDE), or product development protocol (PDP) application. Post-approval studies can provide patients, health care professionals, the device industry, the FDA and other stakeholders information on the continued safety and effectiveness (or continued probable benefit, in the case of an HDE) approved medical devices. This database allows you to search Post-Approval Study information by applicant or device information.

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OSB Lead-5 year registry - ROSE


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General
Application Number P040050 / PAS001
Current Plan Approved 10/30/2006
Study Name OSB Lead-5 year registry - ROSE
General Study Protocol Parameters
Study Design Prospective Cohort Study
Data Source Sponsor Registry
Comparison Group No Control
Analysis Type Descriptive
Study Population Transit. Adolescent B (as adults) : 18-21 yrs, Adult: >21
Detailed Study Protocol Parameters
Study Design Description The Real-Time Observation of Safety and Effectiveness (ROSE) study is a non-randomized, prospective, multi-center, registry of Macroplastique safety and effectiveness.
Study Population Description The study population consists of women at least 18 years of age diagnosed with stress urinary incontinence primarily due to intrinsic sphincter deficiency who are candidates for treatment with the device according to the approved labeling,. This device is indicated for transurethral injection in the treatment of adult women diagnosed with stress urinary incontinence primarily due to intrinsic sphincter deficiency.
Sample Size 275 enrolled patients and maximum of 20 sites
Data Collection The primary endpoints are additional or alternative surgical treatment over a 5-year period and incidence of genitourinary and treatment-related adverse events. Other endpoints collected are: change in Incontinence Quality of Life questionnaire, change in Stamey grade, and change in number of incontinence episodes per day from baseline to 5 years as well as subject perception of treatment success.
Follow-up Visits and Length of Follow-up Subjects are followed for 5 years following initial treatment with Macroplastique or until alternative treatment for stress urinary incontinence.
Final Study Results
Interim Safety Information Five adverse events have occurred in 3 subjects. All of the adverse events were urinary tract infections that were considered mild in severity and unrelated to Macroplastique by the investigator. All events were resolved with medical treatment. Onset of adverse event since last Macroplastique treatment ranged 3-10 months. Onset since first Macroplastique treatment was not indicated (one subject received retreatment).


OSB Lead-5 year registry - ROSE Schedule

Report Schedule
Report
Date Due
FDA Receipt
Date
Applicant's Reporting Status
6 month report 04/30/2007 04/26/2007 On Time
1 year registry report 10/30/2007 11/01/2007 Overdue/Received
18 month registry report 04/29/2008 04/29/2008 On Time
2 year registry report 10/29/2008 10/29/2008 On Time
3 year registry report 10/29/2009 10/29/2009 On Time
4 year registry report 10/29/2010 10/29/2010 On Time
5 year registry report 10/29/2011 10/28/2011 On Time
6 year registry report 10/28/2012 10/26/2012 On Time
7 year report 10/28/2013 10/25/2013 On Time
8 year report 10/28/2014 10/24/2014 On Time
9 year report 10/28/2015 10/15/2015 On Time
10 year report 10/28/2016    


Contact Us

Julie Unger
Project Manager, Post-Approval Studies Program
Food and Drug Administration
10903 New Hampshire Ave
WO66-4206v Silver Spring, MD
20993-0002

Phone: (301) 796-6134
Fax: (301) 847-8140
julie.unger@fda.hhs.gov

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