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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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BD-USLHPV Post-Approval Study


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General
Study Status Completed
Application Number P160037 / PAS001
Study Name BD-USLHPV 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 post-approval study will support the primary screening indication for use of the BD Onclarity HPV Assay on cervical specimens collected in SurePath collection media. The study will consist of women aged 25 years or older who completed the colposcopy procedure in the baseline study but who did not receive treatment. In addition, a random selection of women aged 25 and older who were NILM/HPV negative in the baseline and did not undergo colposcopy/biopsy will also be included. This population encompasses women with abnormal cytology, women who are HPV positive, a subset of women who are HPV negative with normal cytology, and women with unsatisfactory cytology results. Subjects in the follow-up study will undergo annual cytology screening, with women who are ASC-US or worse invited to proceed to colposcopy. This study will provide additional longitudinal information regarding clinical performance of the Onclarity HPV Assay when used in the primary screening algorithm. Sensitivity, specificity, absolute risks, predictive values, and disease likelihood ratios will be calculated, and a benefit/risk analysis will be performed.
Study Population Description Women 25 years of age or older who underwent colposcopy but did not receive treatment in the baseline study; a random selection of women 25 years of age or older who were NILM/HPV negative and did not undergo colposcopy/biopsy in the baseline study.
Sample Size About 9,000 women
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 3 years
Interim or Final Data Summary
Actual Number of Patients Enrolled 6730 subjects are enrolled for this study.
Actual Number of Sites Enrolled Not applicable for this study.
Patient Follow-up Rate The complete follow-up rate is 64% (4313/6730).
Final Safety Findings No procedure related serious adverse events reported.

12 adverse events were reported as probably related with procedure: 16.6% post biopsy

bleeding (2/12), 8.3% pelvic cramping during colposcopy(1/12), 8.3% nausea during

colposcopy(1/12), 8.3% hypotension (1/12), 8.3% abdominal cramping (1/12), 8.3% vaginal

bleeding (1/12), 8.3% vaginal discharge (1/12), 8.3% abnormal uterine bleeding (1/12), 8.3%

urinary tract infection (1), 8.3% vaginal burning (1/12), 8.3% vaginal spotting (1/12).

Four adverse events were reported as possibly related with procedure: 25% vaginal spotting (1),

25% uterine bleeding (1), 25% vaginal bleeding (1), 25% abdominal cramps (1).
Final Effect Findings The VBA cumulative risk of greater than or equal to CIN3 in women with an HPV HR negative result was 0.1% at

baseline as well as Years 1 and Year 2, and 0.2% at Year 3. The VBA cumulative risk of greater than or equal to CIN3 in

women with HPV 12 other HPV HR positive and NILM cytology was 1.9% at baseline, 2.3% at

Year 1 and Year 2, and 2.5% at Year 3.

The VBA cumulative risk of =CIN3 in women with HPV HR 16/18 positive was 12.2% at baseline,

13.9% at Year 1, 14.6% at Year 2, and 16.4% at Year 3. The VBA cumulative risk of greater than or equal to CIN3 in

women with HPV 12 other HPV HR positive and greater than or equal to ASCUS cytology was

5.3% at baseline, 6.5% at Year 1, 7.8% at Year 2, and 8.8% at Year 3.
Study Strengths & Weaknesses Strength:

The study evaluated 3-year long term absolute risk and accumulated risk for =CIN3 in women

with an HPV HR negative result and with HPV HR 16/18 positive result at baseline. The results

are comparable with previously published results for similar HPV assays.

Weakness:

1595 subjects, 23.7% of enrolled subjects, missed at least one follow-up, which may lead to delayed diagnoses and prevention. The follow-up rate at 3 year for subjects completed all three follow-ups is relatively low, 64%, which potentially may introduce bias to the study results.
Recommendations for Labeling Changes Labeling change is recommended to reflect the long-term data from the post-approval study. The labeling change should include a new section on the label showing a summary of the post-approval study methods (including study objectives, design, population, number of enrolled sites/subjects, key endpoint, follow-up visits etc.), final results, study strengths and limitations of the PAS.


BD-USLHPV Post-Approval Study Schedule

Report Schedule
Report
Date Due
FDA Receipt
Date
Applicant's Reporting Status
six month report 08/13/2018 08/10/2018 On Time
one year report 02/12/2019 02/07/2019 On Time
final report 08/13/2019 08/12/2019 On Time


Contact Us

Mandated Studies Program
Food and Drug Administration
10903 New Hampshire Ave.
Silver Spring, MD 20993-0002
Email: MandatedStudiesPrograms@fda.hhs.gov

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