f Post-Approval Studies (PAS) Database
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U.S. Department of Health and Human Services

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

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Short Term (Fitzpatrick)


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General
Study Status Completed
Application Number /
Requirement Number		 P050052 / PAS002
Date Original Protocol Accepted 12/22/2006
Date Current Protocol Accepted 12/22/2006
Study Name Short Term (Fitzpatrick)
Device Name RADIESSE INJECTABLE IMPLANT
General Study Protocol Parameters
Study Design Prospective Cohort Study
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 Objectives This study is a prospective open-label study with no control group. The study was designed to assess the development of keloid formation, hypertrophic scarring, and pigmentation changes.
Study Population This device is indicated for subdermal implantation for the correction of moderate to severe facial wrinkles and folds such as nasolabial folds. The study population includes patients 18 years or older with Fitzpatrick skin types IV-VI who receive Radiesse for treatment of nasolabial folds.
Sample Size 100 patients, 5 sites
Key Study Endpoints There were no primary effectiveness endpoints defined. Adverse events were assessed at 3 month and 6 month office visits.
Follow-up Visits and Length of Follow-up The study required 6 month follow-up. Evaluation was done at baseline, 3 months, and 6 months.
Interim or Final Data Summary
Interim Results Study completed, see final results.
Actual Number of Patients Enrolled 100 patients
Actual Number of Sites Enrolled 5 sites
Patient Follow-up Rate 98%
Final Safety Findings There was one case of hyperpigmentation on the lip noted.
Study Strengths & Weaknesses The weakness of the study was that there was no control group.
Recommendations for Labeling Changes Update labeling to reflect the results of the PAS taking into account study limitations


Short Term (Fitzpatrick) Reporting Schedule

Reporting Schedule
Report
Date Due
FDA Receipt
Date
Applicant's Reporting Status
1 year report short term study 12/22/2007 01/14/2008 Overdue/Received
2 year final report short term 12/21/2008 02/20/2008 On Time


Contact Us
Mandated Studies Program
Food and Drug Administration
10903 New Hampshire Ave.
Silver Spring, MD 20993-0002
Email: MandatedStudiesPrograms@fda.hhs.gov

Additional Resources

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