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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 P040001
Most Recent Protocol Version Approved 12/08/2006
Study Name LTOS 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 Descriptive
Study Population Transit. Adolescent B (as adults) : 18-21 yrs, Adult: >21
Detailed Study Protocol Parameters
Study Design Description The Long-Term Outcomes Study (LTOS) is a prospective, multi-center study of patients who received the   show the rest ...
Study Population Description The study population is comprised of patients aged 50 years and older who have lumbar   show the rest ...
Sample Size The sample size is 155 potential patients who participated in the IDE.
Data Collection The primary effectiveness endpoint is treatment response, defined as follows:- Clinically significant improvement (by at   show the rest ...
Followup Visits and Length of Followup The duration of patient follow-up will be 5 years. The follow-up schedule for the study   show the rest ...
Final Study Results
Actual Number of Patients Enrolled A total of 69 study subjects were enrolled.
Actual Number of Sites Enrolled A total of six study sites were enrolled.
Patient Followup Rate The follow-up rate for enrolled patients was 97.1%.
Final Safety Findings A total of 56 patients were analyzed radiographically at the 5-year postoperative assessment (29 had   show the rest ...
Final Effectiveness Findings The treatment success rate was 45.5% (25/55) for the target cohort and 42.9% (6/14) for   show the rest ...
Study Strengths and Weaknesses Strengths of the study include the duration of follow-up and the conduct of radiographic examinations.



Study   show the rest ...
Recommendations for Labeling Changes Yes, labeling change is recommended to provide long-term, five year data regarding device safety and   show the rest ...


LTOS Study Schedule

Report Schedule
Report
Date Due
FDA Receipt
Date
Reporting Status
18 month report 05/21/2007 05/21/2007 On Time
2 year report 11/21/2007 11/21/2007 On Time
18 month interim report 05/21/2008 05/21/2008 On Time
3 year report 11/21/2008 11/20/2008 On Time
4 year report 11/21/2009 11/18/2009 On Time
5 year report 11/21/2010 11/18/2010 On Time
6 year report - FINAL REPORT 11/25/2011 11/23/2011 On Time

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