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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 TheraBionic P1 Post-Approval Study


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General
Study Status Study Pending
Application Number /
Requirement Number		 H220001 / PAS001
Date Original Protocol Accepted 07/17/2024
Date Current Protocol Accepted  
Study Name The TheraBionic P1 Post-Approval Study
Device Name TheraBionic P1
Clinical Trial Number(s) NCT00534664 NCT04327700 
General Study Protocol Parameters
Study Design Prospective Cohort Study
Data Source New Data Collection
Comparison Group Historical Control
Detailed Study Protocol Parameters
Study Objectives Non-Randomized, Single-Arm Uncontrolled Study to assess Overall Survival using the TheraBionic P1 system for patients with advanced hepatocellular carcinoma (HCC) who have failed two lines of therapy.
Study Population Patients with advanced hepatocellular carcinoma (HCC, defined as a liver tumor not eligible for local therapies given the extent of disease or a liver tumor that recurred after local therapy) who have failed at least two lines of therapy or who that are no longer eligible for any line of standard therapy.
Sample Size Number of subjects: 48
Assumptions for sample size estimation:
Number of sites: 3
Key Study Endpoints The trial will utilize OnCore as the electronic data capture platform. Data will be recorded for all study subjects who, after meeting the inclusion/exclusion criteria and completing the Informed Consent process, receive the TheraBionic P1 device. Incoming data will be monitored to identify inconsistent or missing data and Unanticipated Adverse Device Effects. Data discrepancies will be resolved through routine monitoring of the reported data to source data.
The Prescribing Physician, Clinical Monitor and Sponsor shall maintain subject confidentiality during the review and collection of the study data and inspections of the study site. Study subjects will be identified only by their unique subject number on CRFs, in study correspondence and in the study database. The Prescribing Physician, Clinical Monitor and the Sponsor will take all measures to ensure subject confidentiality is maintained at all times. All subject data retrieved by the Sponsor (or its designee) from the subject medical records must be made anonymous
before retrieval from the study site.
Follow-up Visits and Length of Follow-up Length of follow-up for two years.
Baseline and return visits every 8 weeks


The TheraBionic P1 Post-Approval Study Reporting Schedule

Reporting Schedule
Report
Date Due
FDA Receipt
Date
Applicant's Reporting Status
6 month report 03/26/2024 04/29/2024 Overdue/Received
1 year report 09/25/2024    
18 month report 03/26/2025    
2 year report 09/25/2025    
3 year report 09/25/2026    


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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