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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The Continuation of the Open Liver Clinical Study

General
Study Status	Study Pending
Application Number / Requirement Number	P240035 / PAS001
Date Original Protocol Accepted	01/28/2026
Date Current Protocol Accepted	01/28/2026
Study Name	The Continuation of the Open Liver Clinical Study
Device Name	ETHIZIA
Clinical Trial Number(s)	NCT04819945 NCT05385952 NCT05900037
General Study Protocol Parameters
Study Design	Randomized Clinical Trial
Data Source	Other Data Source
Comparison Group	Concurrent Control
Analysis Type	Descriptive
Study Population	Adult: >21

The Continuation of the Open Liver Clinical Study Reporting Schedule

Reporting Schedule	Report Date Due	FDA Receipt Date	Applicant's Reporting Status
1 year report	12/15/2026
2 year report	12/15/2027
3 year report	12/14/2028
4 year report	12/14/2029

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