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U.S. Department of Health and Human Services

Post-Approval Studies

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Post-Approval Studies

  • In January 2005, the oversight responsibility of the Post-Approval Studies Program was transferred to the Division of Epidemiology (DEPI) of the Office of Surveillance and Biometrics (OSB)/Center for Devices and Radiological Health (CDRH).
  • The CDRH Post-Approval Studies Program encompasses design, tracking, oversight, and review responsibilities for studies mandated as a condition of approval of a premarket approval (PMA) application, protocol development product (PDP) application, or humanitarian device exemption (HDE) application. The program helps ensure that well-designed post-approval studies (PAS) are conducted effectively and efficiently and in the least burdensome manner.
  • CDRH has established an automated, internal tracking system that efficiently identifies the reporting status of active PAS studies ordered since January 1, 2005 based on study timelines incorporated in study protocols and agreed upon by the CDRH and applicants. This system represents CDRH's effort to ensure that all PAS commitments are fulfilled in a timely manner.
  • In addition, CDRH launched this publicly available webpage to keep all stakeholders informed of the progress of each PAS. The webpage displays general information regarding each PAS, as well as the overall study status (based on protocol-driven timelines and the adequacy of the data) and the applicant's reporting status for each submission due.

Links

Contact Information

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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General
Application Number P020018 S010
Most Recent Protocol Version Approved 09/07/2006
Study Name AAA Flex 36mm
Study Status Completed
General Study Protocol Parameters
Study Design Prospective Cohort Study
Study involve follow-up of premarket cohort (Y/N) Yes
Data Source New Data Collection
Comparison Group No Control
Analysis Type Descriptive
Study Population Transit. Adolescent B (as adults) : 18-21 yrs, Adult: >21
Detailed Study Protocol Parameters
Study Design Description The Australian study is a multi-center, non-randomized prospective clinical study, with six Australian sites participating.   show the rest ...
Study Population Description Patients who were implanted with the device in the original study, with an abdominal aortic   show the rest ...
Sample Size 15 Austrailian and 26 US patients
Data Collection Endpoints include: 1) adverse events, 2) endoleaks, 3) secondary interventions, 4) aneurysm enlargement, 5) rupture,   show the rest ...
Followup Visits and Length of Followup Length of follow-up is five years. Patients will be followed on an annual basis.
Final Study Results
Actual Number of Patients Enrolled 41
Actual Number of Sites Enrolled 8
Patient Followup Rate 18% through five years
Final Safety Findings There were no aneurysm-related deaths or conversions to open surgery. There was one ruptured aneurysm   show the rest ...
Final Effectiveness Findings There were no cases of device migration, and aneurysms were far more likely to shrink   show the rest ...
Study Strengths and Weaknesses Follow-up rate was very poor. That plus the fact that the study was very small   show the rest ...
Recommendations for Labeling Changes None. The data from this study do not change current knowledge of device performance


AAA Flex 36mm Schedule

Report Schedule
Report
Date Due
FDA Receipt
Date
Reporting Status
1 year report 09/07/2007 10/11/2007 Overdue/Received
2 year report 09/08/2008 09/08/2008 On Time
3 year report 09/06/2009 09/03/2009 On Time
4 year report 09/06/2010 09/07/2010 Overdue/Received
5 year report-Final Report 09/06/2011 09/02/2011 On Time

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