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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-Radiesse New Enrollment Study


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General
Study Status Progress Adequate
Application Number P050052 S049/ PAS002
Date Current Protocol Accepted 09/18/2017
Study Name OSB Lead-Radiesse New Enrollment Study
General Study Protocol Parameters
Study Design Prospective Cohort Study
Data Source New Data Collection
Comparison Group Concurrent Control
Analysis Type Analytical
Study Population Adult: >21
Detailed Study Protocol Parameters
Study Design Description This is a 2-year, prospective, open-label, new enrollment study in

250 subjects enrolled at up to 12 sites to evaluate the safety and effectiveness of Radiesse implantation for very severe volume loss in the dorsum of the hands in MHGS 4 subjects.

The primary objective is to compare the rate of device/injection- related severe adverse events (AEs) in the Merz Hand Grading Scale (MHGS) 4 group (Group A) versus the MHGS 2/3 group (Group B).

A secondary objective is to assess the effectiveness of Radiesse for very severe volume loss in the dorsum of the hands.

Another secondary objective is to assess the safety of multiple retreatments with Radiesse in the dorsum of the hand.

Study Population Description The study population will consist of subjects who are at least 22 years old with hands rated as MHGS 2, 3, or 4. Additional inclusion and exclusion criteria are specified in the protocol. All subjects will receive an initial treatment with Radiesse and have an opportunity to receive up to 3 additional treatments over the course of this study.
Sample Size A maximum of 250 subjects will be enrolled at a minimum of 5 sites and a maximum of 12 sites in the US.

At 6-months, 244 subjects are expected to provide approximately 80% power to test the hypothesis. With a 5% attrition rate per year, a minimum of 225 evaluable subjects are required to provide 2-year follow-up data.

Data Collection The primary safety endpoint is the 6-month rate of devices/injection-related severe AEs.

The secondary endpoints of the study are:

-The rate of device/injection-related severe adverse events at 24 months

-MHGS at 3-months after initial treatment

-MHGS at 3-months following retreatment for those receiving retreatment

-Global Aesthetic Improvement Scale (GAIS) at 3-months after initial treatment

-GAIS at 3-months following retreatment for those receiving

retreatment

-Hand function testing at baseline, study exit, and other collected time points

o Inter-rater correlation of hand function testing results for each

site

o Differences between sites in hand function testing results

Other endpoints of the study are:

-MHGS at 1-, 6-, 12-, 18-, and 24-months after initial treatment

-MHGS at 1-, 6-, 12- and 18-months follow retreatment for those receiving retreatment

-GAIS at 1-, 6-, 12-, 18-, and 24-months after initial treatment

-GAIS at 1-, 6-, 12- and 18-months follow retreatment for those receiving retreatment

-Michigan Hand Outcomes Questionnaire (MHQ) at baseline, study exit, and other collected time points

-Incidence of all adverse events over the course of the study

Follow-up Visits and Length of Follow-up Subjects will be followed for 24 months.

After screening/enrollment, subjects will be followed at 2 weeks, 1,

3, 6, 7, 12, 13, 18, 19, and 24 months. (The 7 and 19 month visits are only to document serious or medically concerning AEs).



OSB Lead-Radiesse New Enrollment Study Schedule

Report Schedule
Report
Date Due
FDA Receipt
Date
Applicant's Reporting Status
one year report 06/03/2016 06/03/2016 On Time
18 month report 12/09/2016 12/12/2016 Overdue/Received
two year report 06/03/2017 06/02/2017 On Time
three year report 06/03/2018    
final report 12/28/2018    
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

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