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Clinical Trial Summary

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.


Clinical Trial Description

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. ;


Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label


Related Conditions & MeSH terms


NCT number NCT00778531
Study type Interventional
Source Suneva Medical, Inc.
Contact
Status Completed
Phase Phase 4
Start date September 2007
Completion date February 2014

See also
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