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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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The Continuation of the Open Liver Clinical Study


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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: At least 22 yrs
Detailed Study Protocol Parameters
Study Objectives Post-approval observational study; continuation of a pre-market, prospective, randomized (2:1), multicenter pivotal clinical investigation.
The objective of this post-approval study is to evaluate long-term cancer-related outcomes for patients undergoing liver resection for liver malignancy or metastases.
Study Population Subjects undergoing liver resection for liver malignancy or metastases
Sample Size Number of subjects: 105 (68 subject device, 37 TachoSil control)
Assumptions for sample size estimation: N/A
Number of sites: 9
Sites location: United States, Germany, The Netherlands
Key Study Endpoints Observational study with no formal primary endpoints. Exploratory endpoints include:
- Cancer free survival
- Liver cancer free survival
- Local cancer free survival
- Overall survival
These endpoints will undergo subgroup analysis by cancer type (hepatocellular carcinoma, cholangiocarcinoma, colorectal carcinoma metastases, non-colorectal carcinoma metastases, and other cancer)
Follow-up Visits and Length of Follow-up Every 3 months +/- 1 month for the first 12 months.
Every 6 months +/- 3 months until the end of 5 years


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
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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