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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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TS Study


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General
Application Number P060017 / PAS002
Current Plan Approved 10/29/2007
Study Name TS Study
General Study Protocol Parameters
Study Design Cross-Sectional Study
Data Source New Data Collection
Comparison Group No Control
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 designed to address the following objectives: 1) to determine, under clinical use conditions, the assay turn-around-time from the time of node removal to the report of the assay result to the surgeon, 2) to determine, under clinical use conditions, whether the assay result was or was not received in time to make an intra-operative decision, and 3) to collect data in relation to other surgical procedures during the sentinel lymph node dissection/breast surgery to determine if the assay turn arround time resulted in longer surgery time than would have occurred if the assay had not been used.
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 320 patients, 4 sites
Data Collection Assay turn-around-time data was collected on each eligible patient from the time the sentinel lymph node(s) were excised from the patient until the patient assay result was reported back to the surgeon. The relationship to other surgical procedures during the sentinel lymph node dissection/breast surgery will be collected to determine if the assay turn-around-time resulted in longer surgery time than would have occurred if the assay had not been used.
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.


TS Study Schedule

Report Schedule
Report
Date Due
FDA Receipt
Date
Applicant's Reporting Status
6 month report TS Study 01/14/2008 01/11/2008 On Time
1 year report TS Study 07/15/2008 07/11/2008 On Time
21 month progress report 04/20/2009 04/20/2009 On Time
Resp R8 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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