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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 P970021 S014
Most Recent Protocol Version Approved 01/29/2008
Study Name Long-Term Study
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 Analytical
Study Population Adult: >21
Detailed Study Protocol Parameters
Study Design Description Prospective, multi-center, historically controlled study to confirm that the post-procedure incidence of amenorrhea observed with   show the rest ...
Study Population Description 381 subjects with the length of follow-up up to 36-month post-ablation procedure. Among the 381   show the rest ...
Sample Size The study statistical hypotheses, for the rate of amenorrhea, at 24 and 36-month post-procedure are:



A   show the rest ...
Data Collection In addition to clinical visit at week 2, month 6 and 12 post-procedure, patients were   show the rest ...
Followup Visits and Length of Followup Clinical visits were scheduled at week 2, month 6 and 12 months post-procedure. Telephone and/or   show the rest ...
Final Study Results
Actual Number of Patients Enrolled 250
Actual Number of Sites Enrolled 13
Patient Followup Rate 72.4%

Final Safety Findings The incidence of subjects with at least one adverse event was comparable in NPPC and   show the rest ...
Final Effectiveness Findings Analysis #1 (Missing data imputed as failures) ¨C Primary Effectiveness Analysis



The success rate at 36-months   show the rest ...
Study Strengths and Weaknesses Strengths include hypothesis driven sample size that was achieved for the duration of the study   show the rest ...
Recommendations for Labeling Changes Ethicon is required to submit revised labeling to include these long-term results as per their   show the rest ...


Long-Term Study Schedule

Report Schedule
Report
Date Due
FDA Receipt
Date
Reporting Status
6 month report 01/04/2008 12/26/2007 On Time
24 month report 07/05/2008 07/02/2008 On Time
Final Report 11/30/2008 11/28/2008 On Time

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