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U.S. Department of Health and Human Services

Post-Approval Studies (PAS)

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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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OSB Lead-VOLUMA-003 Repeat Treatment Study


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General
Study Status Completed
Application Number P110033 / PAS001
Date Current Protocol Accepted 10/22/2013
Study Name OSB Lead-VOLUMA-003 Repeat Treatment Study
General Study Protocol Parameters
Study Design Other Study Design
Data Source Other Data Source
Comparison Group No Control
Analysis Type Analytical
Study Population Adult: >21
Detailed Study Protocol Parameters
Study Design Description Statistical analysis of data collected in the premarket study
Study Population Description Subjects who enrolled in the premarket study and received repeat treatment
Sample Size At least 167 modified intent-to-treat (mITT) subjects.
Data Collection Safety Endpoints include: presence, severity, location (zygomaticomalar region, anteromedial cheek, and/or

submalar region), and duration of common treatment site responses (CTRs) and any adverse events (AEs) after repeat treatment. There are no effectiveness endpoints.

Follow-up Visits and Length of Follow-up 12 months after repeat treatment

1, 3, 6, 9, and 12 months after repeat treatment

Interim or Final Data Summary
Actual Number of Patients Enrolled 167
Actual Number of Sites Enrolled 14
Patient Follow-up Rate 121/167 (72.5%)
Final Safety Findings Primary endpoint was met because the safety profile of VOLUMA XC after repeat treatment was not inferior (or worse) to the safety profile after initial/touch-up treatment. The incidence of early device/injection-related AEs after repeat treatment [8.4% (14/167)] was not significantly greater than the incidence rate for early device/injection-related AEs [33.5% (56/167)]. In fact, the incidence after repeat treatment was statistically significantly lower (25.1%) than the incidence after initial/touch-up treatment.

No new safety concerns were identified after repeat treatment. The types of case reports and adverse events observed after repeat treatment were similar to those after initial/touch-up treatment, but were generally less severe after repeat treatment. Repeat treatment requires smaller doses and it is known that larger injection volumes lead to significantly higher adverse event rates. Therefore, it was expected that the number of adverse events in the repeat treatment post-approval study would decrease.

A multivariate analysis of the data showed that the rate of device/injection-related adverse events increased with injection volume, was higher in females as compared to males and varied from site to site.
Final Effect Findings This PAS study did not evaluate effectiveness
Study Strengths & Weaknesses Strengths: Multi-center, single-blind, randomized, “no-treatment” control group, adequate sample size.

Weaknesses: Low overall follow-up rate (72.5%).
Recommendations for Labeling Changes The PAS study design, methods and results must be included in the labeling. Additionally, it should be indicated that multivariate analysis showed that the rate of device/injection-related adverse events was different among clinical sites, increased with larger injection volumes, and was higher in females as compared to males.


OSB Lead-VOLUMA-003 Repeat Treatment Study Schedule

Report Schedule
Report
Date Due
FDA Receipt
Date
Applicant's Reporting Status
six month report 04/22/2014 04/18/2014 On Time
one year report-final report 10/22/2014 09/29/2014 On Time


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

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