Post-Approval Studies (PAS) Database

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

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	11/12/2024	On Time
1 year report	05/14/2025
18 month report	11/12/2025
2 year report	05/14/2026

Contact Us

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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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• Guidance Document: "Procedures for Handling Post-Approval Studies Imposed by PMA Order"
• PAS Program Background