|
|
| General |
| Study Status |
Completed |
Application Number /
Requirement Number |
P020012 / PAS001 |
| Date Original Protocol Accepted |
10/27/2006
|
| Date Current Protocol Accepted |
10/27/2006
|
| Study Name |
Study P521-01
|
| Device Name |
ARTEFILL, BELLAFILL PMMA COLLAGEN PERMANENT DERMAL FILLER
|
| 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 multi-center, non-randomized, non-controlled post-approval study.
|
| Study Population |
Subjects who agree to participate and are consecutively treated with Artefill in nasolabial folds (NLF). All subjects must have a negative Artefill skin
test prior to treatment.
|
| Sample Size |
The sample size is 1,000 subjects who agree to participate and are consecutively treated with ArteFill in nasolabial folds. There are to be 25 investigational sites.
|
| Key Study Endpoints |
Endpoints include the incidence of granuloma, incidence of serious unanticipated adverse events (including their severity and relation to the implant product), incidence of anticipated adverse events at each follow-up, and subject's assessment of satisfaction characterized by using a five point non-parametric scale at each follow-up.
|
| Follow-up Visits and Length of Follow-up |
5 years
Patients will be evaluated at baseline before treatment is administered. Follow-up starts at the completion of treatments. The first follow-up visit is at a 3 months after the last treatment, and then using a mail patient questionnaire the sponsor will assess adverse events and subject's satisfaction with treatment at the following intervals from the last treatment:
6, 12, and 18 months, and then 2, 3, 4 and 5 years. at the end of 5 years of follow-up, a final office visit is conducted. During the follow-up period, if a subject indicates the presence of a potential adverse event of a
questionnaire, the sponsor or its representative will contact the investigator caring for that subject. For serious adverse events related to the treatment, the investigator will contact the subject to schedule an appointment to have the event evaluated clinically at the site in a timely manner.
|
| Interim or Final Data Summary |
| Actual Number of Patients Enrolled |
1,008
|
| Actual Number of Sites Enrolled |
23
|
| Patient Follow-up Rate |
87% at 5 years
|
| Final Safety Findings |
Granulomas were encountered in 17 of 1,008 subjects (1.69%). A total of 887 adverse events (AEs) were
noted among 416 (41.3%) treated subjects. There were 177 AEs among 118 (11.7%) treated subjects that were considered device쳌]related. In general, the majority of these events were typical of dermal fillers, mild in severity and resolved during the study period. A total of 101 serious adverse events (SAEs) were noted among 75 (7.4%) treated subjects. In addition to the 7 deaths, there were 94 other SAEs.
The 94 other serious adverse events included one event of difficulty breathing, shortness of breath, or
tightness in the chest, four events of severe illness or trauma, 43 other local complications, and 46 other systemic complications. None of these SAEs were determined to be device쳌]related.
|
| Final Effect Findings |
Subject satisfaction remained high throughout the study. The majority (>83%) of subjects were very satisfied or satisfied (scored 1 or 2 on the 5쳌]point scale) with their treatment outcome at the 5쳌 year follow ]up.
|
| Study Strengths & Weaknesses |
This is a prospective, multicenter study that provides long term data up to 5 years on the safety and effectiveness of the device. The follow ]up rate at 5 years was relatively high (87%). The weakness of the study was the lack of a comparison group.
|
| Recommendations for Labeling Changes |
The labeling will be updated based on the 5쳌 year safety and effectiveness results reported in the PAS
final report.
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