Status:
COMPLETED
Protocol for the Post-approval Study of Artefill for Correction of Nasolabial Folds
Lead Sponsor:
Suneva Medical, Inc.
Conditions:
Granulomatous Disorder
Eligibility:
All Genders
18+ years
Phase:
NA
Brief 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 t...
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 o...
Eligibility Criteria
Inclusion
- 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.
- Subject has a documented negative skin test.
Exclusion
- Subject has any skin pathology or condition that could interfere with the evaluation of the treatment areas.
- Subject has a history of systemic granulomatous diseases active or inactive (e.g.
- Sarcoid, Wegeners, TB, etc.) or connective tissue diseases (.e.g., lupus, dermatomyositis, etc.).
- Subject is immuno-compromised in the opinion of the investigator because of disease or medical therapy (e.g., HIV, use of chemotherapy, etc.)
- Subject has been treated with any of the following in their NLF in the time intervals specified prior to the start of their participation in the study:
- Bovine collagen - 6 months
- Porcine or human collagen - one year
- Hyaluronic acid - one year
- Hydroxylapatite - one year
- Autologous fat - at any time
- Polymethylmethacrylate or other acrylates - at any time
- Polyacrylamide - at any time
- Polyethylene oxide - at any time
- Polylactic acid - at any time
- Liquid silicone - at any time
- Other permanent implant material (FDA approved or not) - at any time
- Subject has had the placement of any surgical implants in the NL folds region (e.g., Gortex, Silastic implants, thread lifts, etc.) at any time.
- Subject has a history of multiple severe allergies or allergies manifested by anaphylaxis.
- Subject has a history of allergy to lidocaine.
- Subject has a history of allergies to any bovine collagen products, including but not limited to injectable collagen, collagen implants, hemostatic sponges, and collagen-based sutures.
- The subject has known hypersensitivity or previous allergic reaction to any of the components of the study devices not previously mentioned.
- Subject is undergoing or planning to undergo desensitization injections to meat products.
- Subject has any condition which, in the Investigator's opinion, would make it unsafe for the subject to participate in this research study.
- Subject is unable to communicate or cooperate with the Investigator due to language problems, poor mental development, or impaired cerebral function.
- Subject may be unreliable for the study including subjects who engage in excessive alcohol intake or drug abuse, or subjects who are unable to return for scheduled follow-up visits.
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Key Trial Info
Start Date :
September 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2012
Estimated Enrollment :
1008 Patients enrolled
Trial Details
Trial ID
NCT03299712
Start Date
September 1 2007
End Date
February 1 2012
Last Update
October 23 2019
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