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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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SURE Study


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General
Application Number P040052 / PAS002
Current Plan Approved 10/18/2007
Study Name SURE Study
General Study Protocol Parameters
Study Design Cross-Sectional Study
Data Source New Data Collection
Comparison Group Concurrent Control
Analysis Type Descriptive
Study Population Adolescent: 13-18 yrs, Transit. Adolescent B (as adults) : 18-21 yrs, Adult: >21
Detailed Study Protocol Parameters
Study Design Description The study was designed to have the 295 pairs (590 individual slides) of slides. Each subject was represented by a pair of slides: a Pap Smear slide and a MonoPrep Pap test slide. The MonoPrep Pap test slide was prepared from the Pap Smear slide residuum. Both sets of slides were assessed for specimen adequacy by the participating laboratories, and the slides were labeled as 'satisfactory' or 'unsatisfactory' accordingly. The adequacy determination (satisfactory/unsatisfactory status) and the underlying reason for an unsatisfactory status according to the TBS2001 criteria. For slides with adequacy determination of satisfactory, a diagnosis was assigned to the slide according to the TBS2001 criteria.
Study Population Description Study Poluation: Women 18 years or older who receive cervical cancer screening. Indication: The MonoGen Pap Test is intended for use in collecting and preparing cervical-vaginal cytology specimens for Pap stain-based screening for cervical cancer, its precursor lesions, and other cytologic categories and conditions defined by the 2001 Bethesda System for Reporting Results of Cervical Cytology.
Sample Size 295 patients, 85 sites
Data Collection The goal of the study was to evaluate cytology slides for adequacy determination and the underlying reason for unsatisfactory status. Data collection consisted of obtaining cervical cytology specimens.
Follow-up Visits and Length of Follow-up Follow-up was not required for this study.
Final Study Results
Interim Safety Information Study completed, see final results.
Number of Patients 295
Number of Sites N/A
Follow-up Rate Follow-up was not required for this study.
Safety Findings The performance of MonoGen Pap Test and Pap Smear methods with regard to "miscall of unsatisfactory slides" are the same.
Strengths & Weaknesses A weakness of the study was that each slide evaluated by only one pathologist and not a panel of pathologists.
Label Changes The sponsor submitted a labeling change. The revisions submitted by the sponsor were not approved.


SURE Study Schedule

Report Schedule
Report
Date Due
FDA Receipt
Date
Applicant's Reporting Status
18 month report SURE 09/04/2007 09/04/2007 On Time
Final Report for SURE Study 09/04/2007 09/04/2007 On Time


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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