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|
| General |
| Study Status |
Completed |
Application Number /
Requirement Number |
P050052 / PAS001 |
| Date Original Protocol Accepted |
12/22/2006
|
| Date Current Protocol Accepted |
12/22/2006
|
| Study Name |
Long Term (Nasolabial Folds)
|
| 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 desgined to extend the follow-up patients enrolled in the premarket study. Patients will be followed for 3 years after the date of their first Radiesse study injection in the premarket study.
|
| Study Population |
This device is indicated for subdermal implantation for the correction of moderate to severe facial wrinkles and folds such as nasolabial folds. Thr study population includes premarket study population.
|
| Sample Size |
100 subjects, 4 sites
|
| Key Study Endpoints |
There were no primary effectiveness endpoints defined. Patients were assessed for the late onset of Radiesse adverse reactions experienced since their last visit. Late onset adverse reactions included nodule, granuloma, necrosis, erosion, or infection.
|
| Follow-up Visits and Length of Follow-up |
The study required 3 year follow-up. As a part of the post-market requirement, study participants had one or two additonal visits to meet the 3 year follow-up requirement.
|
| Interim or Final Data Summary |
| Interim Results |
Study completed, see final results.
|
| Actual Number of Patients Enrolled |
102 of the 117 patients who participated in premarket study enrolled 99 of the 102 subjects compltede 2 study visits and 3 years of follow-up
|
| Actual Number of Sites Enrolled |
4 sites
|
| Patient Follow-up Rate |
97%
|
| Final Safety Findings |
No adverse events were reported by the study although its purpose was to collect long-term safety information on the use of the device and to assess the effect of multiple injections. Expected immediate post-injection site adverse events were not collected either.
|
| Study Strengths & Weaknesses |
The weakness of the study was that there was no control group. Study weaknesses inlcude the the following: The safety assessment is confounded by the use of other dermal fillers or Botulinum Toxin. The PAS did not collect information about the exact date of Radiesse injections; only approximate date is provided. This report does not provide the volume of Radiesse injection either.
|
| Recommendations for Labeling Changes |
Update labeling to reflect the results of the PAS taking into account study limitations
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