|
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.
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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.
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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.
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Study Strengths & Weaknesses |
The weakness of the study was that there was no control group.
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Recommendations for Labeling Changes |
Labeling change were submitted by the manufacturer. The revisions submitted by the sponsor were not approved.
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