An interventional study of ArteFill in Granulomatous Disorder, sponsored by Suneva Medical, Inc.. Completed. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-10-23.
Sponsored by Suneva Medical, Inc. · Not applicable, Interventional, and Other
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.
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.
Exclusion Criteria:
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 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:
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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This post-approval study will 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
soft tissue filler
The incidence of granuloma formation.
To determine the incidence of granuloma formation.
Time frame: 5 years
Incidence of unanticipated adverse events
Safety will be assessed based on the incidence of serious unanticipated adverse events. Unanticipated adverse events will be characterized by the severity and relation to the implant product.
Time frame: 5 years
Incidence of anticipated adverse events
The incidence of anticipated adverse events will be assessed at each follow-up visit.
Time frame: 5 years
Assess of subject satisfaction
Subjects assessed their satisfaction using the 5-point Likert Scale Subject Satisfaction Assessment Scale. This scale has the following measurements: 1- Very Satisfied, 2=Satisfied, 3=Somewhat Satisfied, 4= Dissatisfied and 5=Very Dissatisfied.
Time frame: 5 years
No study locations are listed for this record.
This study is completed, as verified in Oct 2019. You cannot join it, but the record below documents what was studied.
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Suneva Medical, Inc.