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U.S. Department of Health and Human Services

Post-Approval Studies (PAS) Database
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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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SHIP-Sub-Protocol LMI-001-A-S01


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General
Study Status Study Pending
Application Number /
Requirement Number		 P160037 S017/ PAS001
Date Original Protocol Accepted 05/14/2024
Date Current Protocol Accepted  
Study Name SHIP-Sub-Protocol LMI-001-A-S01
Device Name BD Onclarity HPV Assay
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 Objectives The study will include 500 or more individuals with a cervix, 25 years or older, with referrals to colposcopy based on previous positive HPV test or abnormal cytology results. The study will provide additional data regarding clinical performance of the BD Onclarity HPV Assay with vaginal specimens in a U.S. population. The clinical sensitivity, clinical specificity and false positive rate in detecting precancer/cancer as well as the corresponding ratio between vaginal and cervical specimens will be evaluated. Additionally, the concordance of the BD Onclarity HPV Assay results between the two sepecimen types will be evaluated.
Study Population Individuals with a cervix, 25 years or older, who come to colposcopy with a referral based on previous positive HPV test or abnormal cytology results.
Sample Size 500 or more
Study sites will be 10 or more
Key Study Endpoints The clinical sensitivity, clinical specificity and false positive rate in detecting precancer/cancer as well as the corresponding ratio between vaginal and cervical specimens.

The concordance of the BD Onclarity HPV Assay results between the two specimen types.
Follow-up Visits and Length of Follow-up To be eligible to participate in this study, an individual must meet all the following criteria:
• Willingness and ability to provide a documented informed consent.
• Is 25 years or older.
• Has an intact cervix.
• Has had a colposcopy referral in which routine cervical cancer screening has included HPV testing (HPV primary screening, co-testing, or ASC-US cytology triage) or abnormal cytology performed within 12 weeks preceding the colposcopy visit.
• Willing and able to undergo colposcopy, and if clinically indicated for Standard of Care (SOC) purposes, a biopsy, and/or endocervical curettage.

No follow-up, unless required for SOC clinical care purposes


SHIP-Sub-Protocol LMI-001-A-S01 Reporting Schedule

Reporting Schedule
Report
Date Due
FDA Receipt
Date
Applicant's Reporting Status
6 month report 11/12/2024    


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

Additional Resources

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