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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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COB-HPV-301 Post Approval Study


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General
Study Status Completed
Application Number P100020 S017/ PAS001
Date Current Protocol Accepted  
Study Name COB-HPV-301 Post Approval Study
General Study Protocol Parameters
Study Design Cross-Sectional 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 study includes 10,000 women, 25 years or older from a general screening population for cervical disease. All subjects have results of the cytology test from specimens collected in Sure PathPreservative Fluid and cobas HPV Test results with SurePath specimens. Subjects with either abnormal or UNSAT Pap or positive cobas HPV Test results are referred to colposcopy/biopsy procedures. In addition, 250 subjects with NILM cytology and negative HPV results will be referred to colposcopy/biopsy. The study provides additional data regarding the clinical performance of the cobas HPV Test with SurePath samples as sensitivity, specificity, likelihood ratios, and predictive values for women 30 years or older and for women 25 years or older with ASC-US (atypical squamous cells of undetermined significance) cervical cytology test results.
Study Population Description Women 25 years of age or older from a general screening population for cervical disease
Sample Size 10,000 or more
Data Collection greater than or equal to CIN2 (Cervical Intraepithelial Neoplasia) and greater than or equal to CIN3 by colposcopic examination
Follow-up Visits and Length of Follow-up A need for the follow-up study and the length of the follow-up depends on the estimates of clinical performance of the cobas HPV Test with SurePath specimens. Decision about the need of a follow-up study will be made based on the difference in risks of cervical disease for women with negative cobas HPV Test results and/or with positive Other 12 HR HPV cobas HPV Test and NILM cytology results estimated in the study in comparison with the risks for similar groups of women in the ATHENA study.
Interim or Final Data Summary
Actual Number of Patients Enrolled 8095 women aged 30 years and older with NILM cytology were enrolled in the clinical study. Of those enrolled, 8088 women were evaluable.
Actual Number of Sites Enrolled Subjects were enrolled at 11 U.S. sites.
Patient Follow-up Rate Not applicable.
Final Safety Findings No severe adverse events were reported.
Final Effect Findings In the current study, it was demonstrated that the risks of cervical disease (greater than or equal to CIN2 and greater than or equal to CIN3 determined by colposcopy/biopsy) for women with HPV 16/18 positive results or with 12 Other HR HPV positive results obtained by cobas HPV Test in SurePath Preservative Fluid were higher than the risk of the cervical disease for women with cobas HPV Test negative results. In addition, these risks were compared to the corresponding risks when using an FDA-approved HPV test and the study demonstrated that these risks were similar.
Study Strengths & Weaknesses Study strength: Women who were HPV negative and had NILM cytology were sent to colposcopy in the clinical study. The colposcopy results allowed estimation of the sensitivity and specificity of the device.

Study weakness:

Biopsy results of greater than or equal to CIN2 in NILM HPV negative women may not be definitive of cervical disease without follow-up information.
Recommendations for Labeling Changes Labeling incorporating the data from post approval study was submitted and approved.


COB-HPV-301 Post Approval Study Schedule

Report Schedule
Report
Date Due
FDA Receipt
Date
Applicant's Reporting Status
six month report 01/05/2017 01/12/2017 Overdue/Received
one year report 06/02/2017 09/07/2017 Overdue/Received
two year report/final report 07/07/2018 05/07/2018 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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