• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Post-Approval Studies (PAS)

  • Print
  • Share
  • E-mail
-

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

Learn more...


             

OSB Lead-Radiesse Radiological Evaluation Study


Suggest Enhancement / Report Issue | export reports to excelExport to Excel
General
Study Status Progress Adequate
Application Number P050052 S049/ PAS001
Date Current Protocol Accepted 04/26/2017
Study Name OSB Lead-Radiesse Radiological Evaluation Study
General Study Protocol Parameters
Study Design Prospective Cohort Study
Data Source New Data Collection
Comparison Group No Control
Analysis Type Descriptive
Study Population Adult: >21
Detailed Study Protocol Parameters
Study Design Description This is a 2-year, prospective, open-label, new enrollment PAS evaluating the radiographic appearance of Radiesse implantation in the dorsum of the hands.
Study Population Description Adults who are at least 22 years old with hands rated as MHGS 2, 3, or 4 at baseline. There is no comparison group in this study.
Sample Size Twenty subjects (10 subjects with MHGS 4 and 10 subjects with MHGS 2 or 3) will be enrolled at 1 site in the U.S. The sample size is not based on power calculations for a formal statistical hypothesis test, but rather is based on a clinically relevant sample of subjects that will provide a degree of characterization regarding the ability to perform radiologic evaluations after treatment with Radiesse.
Data Collection The main study endpoint is the incidence of obscuration of the bones of the hand at 1-, 6-, 12-, and 24-months following injection of Radiesse in the dorsum of the hand. Other safety endpoints include: hand function testing and MHQ; incidence of device/injection-related severe AEs; and incidence of all AEs. Secondary effectiveness endpoints include MHGS ratings by a masked evaluator and subject-reported GAIS score.
Follow-up Visits and Length of Follow-up 2 years



Follow-up in-clinic visits at months 1, 6, 12, 18, and 24. If repeat injections are administered at any of the 6-, 12-, or 18-month visits, subjects will receive a 72-hour phone call following each injection and return for follow-up visits 1 month post-injection at months 7, 13, and/or

19 respectively.



OSB Lead-Radiesse Radiological Evaluation Study Schedule

Report Schedule
Report
Date Due
FDA Receipt
Date
Applicant's Reporting Status
six month report 12/03/2015 12/03/2015 On Time
one year report 06/03/2016 05/31/2016 On Time
18 month report 12/02/2016 12/02/2016 On Time
two year report 06/03/2017 06/02/2017 On Time
three year report 06/03/2018    
four year report 06/03/2019    
five year report 06/02/2020    


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

Related Links

-
-