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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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Deep Hyperthermia and Radiation


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General
Study Status Redesigned/Replaced Study
Application Number /
Requirement Number		 H090002 / PAS001
Date Original Protocol Accepted 11/18/2011
Date Current Protocol Accepted 11/13/2013
Study Name Deep Hyperthermia and Radiation
Device Name BSD-2000 HYPERTHERMIA SYSTEM
General Study Protocol Parameters
Study Design Prospective Cohort Study
Data Source Sponsor Registry
Comparison Group No Control
Analysis Type Descriptive
Study Population Transit. Adolescent B (as adults) : 18-21 yrs, Adult: >21
Detailed Study Protocol Parameters
Study Objectives Interventional; Open Label; Uncontrolled; Registry
Study Population Females that are 21 and older that are ineligible to undergo chemotherapy.
Sample Size All patients treated with the BSD-2000 over the 3-year enrollment period
Key Study Endpoints 1st endpoint - complete tumor response (CR); 2nd endpoints - safety (i.e. adverse events and toxicity) and survival determined from day 0
Follow-up Visits and Length of Follow-up Up to 36 months after enrollment and expect follow-up completion to be done 72 months following study.
Follow-up exams will be performed at 3, 6, 12, 18, 24, and 36 month intervals.


Deep Hyperthermia and Radiation Reporting Schedule

Reporting Schedule
Report
Date Due
FDA Receipt
Date
Applicant's Reporting Status
six month report 05/18/2012 05/15/2012 On Time
18 month report 05/18/2013 05/15/2013 On Time


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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