Protocol for the Post-approval Study of ArteFill® for Correction of Nasolabial Folds
The purpose of this post-approval study is to evaluate the continuing safety of ArteFill as an injectable implant for correction of nasolabial folds over the course of five years post implantation, with a focus on determining the incidence of granuloma formation. Incidence of adverse events and subject satisfaction with respect to the subject's personal expectations will be assessed.
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
|Official Title:||Protocol for the Post-approval Study of ArteFill® for Correction of Nasolabial Folds|
- The incidence of granuloma formation will be determined. The overall assessment of safety will be based on the incidence of serious unanticipated adverse events. Incidence of anticipated adverse events will be assessed at each follow-up period. [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]
- The subject's assessment of satisfaction will be characterized using a non-parametric five-point scale at each follow-up period. [ Time Frame: 5 years ] [ Designated as safety issue: No ]
|Study Start Date:||September 2007|
|Study Completion Date:||February 2014|
|Primary Completion Date:||February 2014 (Final data collection date for primary outcome measure)|
This study was a multi-center, open-label, post-approval study
Device: ArteFill injectable implant
Treatment will be according to the approved labeling for ArteFill for the correction of nasolabial folds. The nasolabial fold is the line or fold that extends from approximately the inferior aspect of the ala of the nose to the commissure of the mouth on the right and left side of the face.
This study is a multi-center, non-randomized, non-controlled post-approval study designed to follow a total of 1000 consecutive qualified and consenting subjects treated with ArteFill in the course of clinical practice at approximately twenty-five centers. All potential qualifying subjects at a given site should be given the opportunity to participate in the study. Inclusion and exclusion criteria will be limited to those in the approved labeling for ArteFill and treatment will be according to the approved product labeling. Subjects must have a previously documented negative skin test prior to treatment.
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