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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Radiesse


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General
Study Status Completed
Application Number /
Requirement Number		 P050037 / PAS001
Date Original Protocol Accepted 12/22/2006
Date Current Protocol Accepted 12/22/2006
Study Name Radiesse
Device Name RADIESSE 1.3CC AND 0.3CC
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 is a prospective cohort study desgined to extend the follow-up patients enrolled in the premarket study. Patients will be followed for 18-months.
Study Population This device is indicated for subdermal implantation for restoration and/or correction of the signs of facial fat loss (lipoatrophy) in people with human immunodeficiency virus (HIV). The study population includes patients with facial lipoatrophy due to antiretroviral therapy for human immunodeficiency virus.
Sample Size 98 patients, 3 sites
Key Study Endpoints At the 18-month visit, subjects had a Global Aesthetic Improvement Scale assessment, photograph, skin thickness measurement, patient satisfaction assessment, CD4+ cell count and viral load test, and recording of adverse events and medications.
Follow-up Visits and Length of Follow-up The study required 18 month follow-up. As a part of the post-market requirement, study participants had one additonal visits at 18 months.
Interim or Final Data Summary
Interim Results Study completed, see final results.
Actual Number of Patients Enrolled 92 patients
Actual Number of Sites Enrolled 3 sites
Patient Follow-up Rate 92%
Final Safety Findings Adverse events including allergic reaction, ecchymosis, edema, embolization, erosion, erythema, extrusion, granuloma, hematoma, infection, necrosis, needle jam, nodule, pain, and pruritis were noted. Most of these adverse events coincided with the device injection time.
Study Strengths & Weaknesses The weakness of the study was that there was no control group.
Recommendations for Labeling Changes Labeling change were submitted by the manufacturer. The revisions submitted by the sponsor were not approved.


Radiesse Reporting Schedule

Reporting Schedule
Report
Date Due
FDA Receipt
Date
Applicant's Reporting Status
18 month report (follow-up IDE Cohort) 02/09/2007 02/09/2007 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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