Protocol for the Post-approval Study of ArteFill® for Correction of Nasolabial Folds
The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2009 by Suneva Medical, Inc..
Recruitment status was Active, not recruiting
Information provided by:
Suneva Medical, Inc.
First received: October 21, 2008
Last updated: September 4, 2009
Last verified: September 2009
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.
Device: ArteFill injectable implant
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
||Protocol for the Post-approval Study of ArteFill® for Correction of Nasolabial Folds
Primary Outcome Measures:
- 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 ]
Secondary Outcome Measures:
- 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 ]
| Estimated Enrollment:
| Study Start Date:
| Estimated Study Completion Date:
| Estimated Primary Completion Date:
||January 2014 (Final data collection date for primary outcome measure)
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.
|Ages Eligible for Study:
||18 Years and older
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
- Subject is male or non-pregnant female 18 years of age or older.
- Subject has provided written and verbal informed consent.
- Subject is willing to comply with study instructions and return to the clinic for required visits.
- Subject is willing to withhold additional aesthetic implant therapies to the NLF [e.g., other soft tissue fillers: Restylane, Silicone, Radiesse, Sculptra) or implants: gortex, silastic, thread lift, etc.] for the duration of the study.
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
No Contacts or Locations Provided
No publications provided
||Karon Morell, Sr. VP Regulatory and Quality Affairs, Suneva Medical, Inc.
History of Changes
|Other Study ID Numbers:
||Protocol 521-01, D82-3002-07
|Study First Received:
||October 21, 2008
||September 4, 2009
||United States: Institutional Review Board
Keywords provided by Suneva Medical, Inc.:
Correction of nasolabial folds
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on September 22, 2014
Physiological Effects of Drugs