NCT03299712

Protocol for the Post-approval Study of Artefill for Correction of Nasolabial Folds

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 1,008 (actual)
• Sponsor: Suneva Medical, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

This study is a five-year, 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 and all subjects must have a previously documented negative skin test prior to receiving treatment. The incidence of granuloma formation will be monitored.

Detailed 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. Follow-up for subject-reported potential adverse events and satisfaction data will be by mail or telephone questionnaire survey every six months for the first two years after the final treatment session and then every year for a total of five years of follow-up. The subject will be contacted by his or her investigator if a problem is identified in the questionnaire response as reviewed by the Sponsor or their designee. Potential adverse events reported in the follow-up questionnaires will be investigated further by means of office visits, as necessary, or via telephone. Adverse events will be confirmed and reported by the investigators. If an adverse event is determined by the investigator to possibly be a granuloma, it will be investigated via histology. If a subject for whom an adverse event is reported has received additional aesthetic or non-aesthetic treatment to the affected area, available information on such treatment will be collected and the subject will be continued to be followed per protocol. Such subjects will not be excluded from the analysis, but will be evaluated separately. Effectiveness data will be collected during the study and will consist of the subject's assessment of satisfaction with treatment.

Conditions

• Granulomatous Disorder

Interventions

Type	Name	Description
DEVICE	ArteFill	soft tissue filler

Timeline

• Start date: 2007-09-01
• Primary completion: 2012-02-01
• Completion: 2012-02-01
• First posted: 2017-10-03
• Last updated: 2019-10-23