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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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CHOICE Study


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General
Application Number P040052 / PAS001
Current Plan Approved 12/18/2007
Study Name CHOICE Study
General Study Protocol Parameters
Study Design Cross-Sectional Study
Data Source New Data Collection
Comparison Group Historical 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 consists of consecutive patients for whom a MonoGen Pap Test is performed at the participating laboratories constitute the MonoGen Pap Test arm of this study. These patiens will be compared to historical Pap smear slides from the same laboratories.
Study Population Description Study Population: Patients 18 years or older, with a Pap test and a minimum of 400 HSIL. There were also 360 patients who have an accompanying colposcopy/biopsy results. Indication: The MPPT 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 400 HSIL patients and 360 patients with an accompanying colposcopy/biopsy, 3 sites
Data Collection Data will be collected on the MonoGen Pap test results for MPPT patients and Pap smear results will be obtained from the control patients. The endpoint includes cervical cytology results from cervical-vaginal cytology specimens using both MPPT method for the prospective arm and PS method for the historical arm. For cases with cytologic diagnosis of HSIL+ from both MPPT and PS arms, comparative data from histological examination (colposcopy and, if appropriate, biopsy) will be collected.
Follow-up Visits and Length of Follow-up Follow-up was not required for this study.
Final Study Results
Interim Safety Information The study was terminated early because the sponsore does not intend to market the device.


CHOICE Study Schedule

Report Schedule
Report
Date Due
FDA Receipt
Date
Applicant's Reporting Status
6 month progress report - meeting request 08/03/2006 08/03/2006 On Time
1 year status report 03/03/2007 03/02/2007 On Time
18 month report CHOICE 09/04/2007 09/04/2007 On Time
2 year report CHOICE 03/02/2008 03/03/2008 Overdue/Received
30 month report CHOICE 08/31/2008 09/02/2008 Overdue/Received


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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