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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) of approved medical devices. This database allows you to search Post-Approval Study information by applicant or device information.

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OSB Lead-Prolieve PAS


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General
Study Status Progress Adequate
Application Number P030006 / PAS001
Date Current Protocol Accepted 03/11/2005
Study Name OSB Lead-Prolieve PAS
General Study Protocol Parameters
Study Design Prospective Cohort Study
Data Source New Data Collection
Comparison Group No Control
Analysis Type Descriptive
Study Population Adult: >21
Detailed Study Protocol Parameters
Study Design Description This is an open label non-randomized prospective study . The primary objective of the study is to provide descriptive data on the long-term safety and effectiveness of Prolieve for Benign Prostate Hyperplasia . A secondary objective is to assess safety and effectiveness of re-treatment and to assess the proportion of patients electing re-treatment with Prolieve compared to alternative therapy (other localized therapy, surgery or drug therapy).
Study Population Description Study population is as per device indication. Adult men men with prostate volume of 20 to 80 grams and in whom drug therapy (Proscar) is typically indicated.
Sample Size The protocol proposes to enroll 250 new subjects in up to 30 study sites in the United States. The protocol states this will ensure at least 100 subjects will be followed for 5 years. In addition to newly enrolled subjects, the sponsor planned to encourage Pivotal Study participants and Continued Access Study participants to transfer to the postmarket study for the completion of 5 years of follow-up
Data Collection Efficacy is evaluated using the following: Time to re-treatment, American Urological Association (AUA) Symptom Index, (Classifies the severity of subject symptoms related to urinary difficulties based on seven questions that form a total score. The score can range from 0-35). Pain/Discomfort, Sexual Function, Impact of Lower Urinary Tract Symptoms (LUTS) on quality of life (QOL), (Six questions related to urinary problems and how they interfere with daily living. The score ranges from 5-24), Quality of Life Questionnaire, (Six questions related to the subjects feelings about his urinary condition, perception of urinary difficulties, sexual function, activities of daily living, general well-being and social activities. The seven-point scale ranges from delighted to terrible and scores can range from 6-42), Brief Symptom Inventory (BSI), (Seven questions related to the interference of the subject s urinary problems with common activities, scores range from 7-35), BPH Impact Index (BII), (Four questions related to concern about urinary problems and the amount of physical discomfort experienced. Scores can range from 4-17. Safety is measured by: Use of pain medication pre-treatment and during treatment, Pain associated with treatment, Local and systemic symptoms during Prolieve treatment

Catheterizations associated with treatment, PSA levels, Adverse events, Anticipated adverse events (associated with treatment or BPH), Hospitalizations , and MDR reportable events.
Follow-up Visits and Length of Follow-up Study participants are to be evaluated at two weeks, three months and annually thereafter for a period of 5 years after treatment with Prolieve.


OSB Lead-Prolieve PAS Schedule

Report Schedule
Report
Date Due
FDA Receipt
Date
Applicant's Reporting Status
2 year report 02/18/2006 03/20/2006 Overdue/Received
3 year report 02/18/2007 07/02/2007 Overdue/Received
4 year report 02/18/2008 02/19/2008 On Time
5 year report 02/17/2009 02/18/2009 Overdue/Received
6 year report 02/19/2010 02/19/2010 On Time
7 year report 02/22/2011 02/22/2011 On Time
72 month report 02/18/2013 12/21/2012 On Time
7 year report (83 month) 04/18/2014 04/21/2014 Overdue/Received
8 year report 05/18/2015 05/14/2015 On Time
9 year report 06/18/2016 06/21/2016 Overdue/Received
10 year report/final report 06/02/2017 06/15/2017 Overdue/Received
11 year report 04/18/2018    
final report 12/18/2019    


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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