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U.S. Department of Health and Human Services

Post-Approval Studies (PAS)

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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) approved medical devices. This database allows you to search Post-Approval Study information by applicant or device information.

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PPC Study


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General
Application Number P060017 / PAS001
Current Plan Approved 10/29/2007
Study Name PPC Study
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 Design Description 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 Description 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
Data Collection 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.
Final Study Results
Interim Safety Information The study was terminated early by the sponsor in Dec 2009 due to to the decision to no longer market the GeneSearch Breast Lymph Node Assay in the United States.


PPC Study Schedule

Report 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

Julie Unger
Project Manager, Post-Approval Studies Program
Food and Drug Administration
10903 New Hampshire Ave
WO66-4206v Silver Spring, MD
20993-0002

Phone: (301) 796-6134
Fax: (301) 847-8140
julie.unger@fda.hhs.gov

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