f Post-Approval Studies (PAS) Database
Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Post-Approval Studies (PAS) Database
  • Print
  • Share
  • E-mail
-

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.

Learn more...


           

PPC Study


Suggest Enhancement / Report Issue | export reports to excelExport to Excel
General
Study Status Other
Application Number /
Requirement Number		 P060017 / PAS001
Date Original Protocol Accepted 10/29/2007
Date Current Protocol Accepted 10/29/2007
Study Name PPC Study
Device Name GENESEARCH BREAST LYMPH NODE(BLN) ASSAY
General Study Protocol Parameters
Study Design Cross-Sectional Study
Data Source New Data Collection
Comparison Group Objective Performance Criterion
Analysis Type Analytical
Study Population Transit. Adolescent B (as adults) : 18-21 yrs, Adult: >21
Detailed Study Protocol Parameters
Study Objectives The post-approval study is a clinical study to estimate the positive predictive concordance between the breast lymph node assay and histology as routinely practiced i.e., routine hematoxylene and eosin histology of sentinel lymph node(s), and when available, routine histology of non-sentinel axillary lymph nodes. The positive predictive concordance value is defined as the proportion of breast lymph node assay positive subjects with histologically detectable breast cancer metastases.
Study Population Study Population: Breast cancer patients. Indication: The device is indicated as an in vitro diagnostic test for the rapid detection of greater than 0.2 mm metastases in nodul tissue removed from the sentinel lymph nodes biopsies of breast cancer patients.
Sample Size 1,000 female or male patients to include a minimum of 246 breast lymph node positive patients, 4 sites
Key Study Endpoints The primary endpoint is the efficacy endpoint as measured as a metric that uses the less thorough reference. The metric is the positive predictive concordance between the breast lymph node assay and histology as routinely practiced i.e., routine hematoxylene and eosin, histology of sentinel lymph node(s), and when available, routine histology of non-sentinel axillary lymph nodes.
Follow-up Visits and Length of Follow-up Follow-up was not required for this study.


PPC Study Reporting Schedule

Reporting Schedule
Report
Date Due
FDA Receipt
Date
Applicant's Reporting Status
6 month report PPC Study 01/14/2008 01/11/2008 On Time
1 year report PPC Study 07/15/2008 07/11/2008 On Time
18 month report PPC Study 01/13/2009 01/13/2009 On Time
21 month progress report 04/20/2009 04/20/2009 On Time
Resp R7 RDEF & 24 month report 07/19/2009 07/21/2009 Overdue/Received
27 month report 10/15/2009 10/13/2009 On Time
Final report 01/13/2010 04/30/2010 Overdue/Received


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

-
-