<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03299712</url>
  </required_header>
  <id_info>
    <org_study_id>521-01</org_study_id>
    <nct_id>NCT03299712</nct_id>
    <nct_alias>NCT00778531</nct_alias>
  </id_info>
  <brief_title>Protocol for the Post-approval Study of Artefill for Correction of Nasolabial Folds</brief_title>
  <official_title>Protocol for the Post-approval Study of Artefill for Correction of Nasolabial Folds</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Suneva Medical, Inc.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Suneva Medical, Inc.</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study is a five-year, multi-center, non-randomized, non-controlled post-approval study&#xD;
      designed to follow a total of 1000 consecutive qualified and consenting subjects treated with&#xD;
      ArteFill® in the course of clinical practice at approximately twenty-five centers and all&#xD;
      subjects must have a previously documented negative skin test prior to receiving treatment.&#xD;
      The incidence of granuloma formation will be monitored.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This study is a multi-center, non-randomized, non-controlled post-approval study designed to&#xD;
      follow a total of 1000 consecutive qualified and consenting subjects treated with ArteFill®&#xD;
      in the course of clinical practice at approximately twenty-five centers. All potential&#xD;
      qualifying subjects at a given site should be given the opportunity to participate in the&#xD;
      study. Inclusion and exclusion criteria will be limited to those in the approved labeling for&#xD;
      ArteFill® and treatment will be according to the approved product labeling. Subjects must&#xD;
      have a previously documented negative skin test prior to treatment. Follow-up for&#xD;
      subject-reported potential adverse events and satisfaction data will be by mail or telephone&#xD;
      questionnaire survey every six months for the first two years after the final treatment&#xD;
      session and then every year for a total of five years of follow-up. The subject will be&#xD;
      contacted by his or her investigator if a problem is identified in the questionnaire response&#xD;
      as reviewed by the Sponsor or their designee. Potential adverse events reported in the&#xD;
      follow-up questionnaires will be investigated further by means of office visits, as&#xD;
      necessary, or via telephone.&#xD;
&#xD;
      Adverse events will be confirmed and reported by the investigators. If an adverse event is&#xD;
      determined by the investigator to possibly be a granuloma, it will be investigated via&#xD;
      histology. If a subject for whom an adverse event is reported has received additional&#xD;
      aesthetic or non-aesthetic treatment to the affected area, available information on such&#xD;
      treatment will be collected and the subject will be continued to be followed per protocol.&#xD;
      Such subjects will not be excluded from the analysis, but will be evaluated separately.&#xD;
      Effectiveness data will be collected during the study and will consist of the subject's&#xD;
      assessment of satisfaction with treatment.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>September 2007</start_date>
  <completion_date type="Actual">February 2012</completion_date>
  <primary_completion_date type="Actual">February 2012</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Other</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>The incidence of granuloma formation.</measure>
    <time_frame>5 years</time_frame>
    <description>To determine the incidence of granuloma formation.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Incidence of unanticipated adverse events</measure>
    <time_frame>5 years</time_frame>
    <description>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.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Incidence of anticipated adverse events</measure>
    <time_frame>5 years</time_frame>
    <description>The incidence of anticipated adverse events will be assessed at each follow-up visit.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Assess of subject satisfaction</measure>
    <time_frame>5 years</time_frame>
    <description>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.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">1008</enrollment>
  <condition>Granulomatous Disorder</condition>
  <arm_group>
    <arm_group_label>ArteFill</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>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.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>ArteFill</intervention_name>
    <description>soft tissue filler</description>
    <arm_group_label>ArteFill</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Subject is male or non-pregnant female 18 years of age or older.&#xD;
&#xD;
          2. Subject has provided written and verbal informed consent.&#xD;
&#xD;
          3. Subject is willing to comply with study instructions and return to the clinic for&#xD;
             required visits.&#xD;
&#xD;
          4. Subject is willing to withhold additional aesthetic implant therapies to the NLF&#xD;
             [e.g., other soft tissue fillers: Restylane, Silicone, Radiesse, Sculptra) or&#xD;
             implants: gortex, silastic, thread lift, etc.] for the duration of the study.&#xD;
&#xD;
          5. Subject has a documented negative skin test.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Subject has any skin pathology or condition that could interfere with the evaluation&#xD;
             of the treatment areas.&#xD;
&#xD;
          2. Subject has a history of systemic granulomatous diseases active or inactive (e.g.&#xD;
&#xD;
             Sarcoid, Wegeners, TB, etc.) or connective tissue diseases (.e.g., lupus,&#xD;
             dermatomyositis, etc.).&#xD;
&#xD;
          3. Subject is immuno-compromised in the opinion of the investigator because of disease or&#xD;
             medical therapy (e.g., HIV, use of chemotherapy, etc.)&#xD;
&#xD;
          4. Subject has been treated with any of the following in their NLF in the time intervals&#xD;
             specified prior to the start of their participation in the study:&#xD;
&#xD;
               -  Bovine collagen - 6 months&#xD;
&#xD;
               -  Porcine or human collagen - one year&#xD;
&#xD;
               -  Hyaluronic acid - one year&#xD;
&#xD;
               -  Hydroxylapatite - one year&#xD;
&#xD;
               -  Autologous fat - at any time&#xD;
&#xD;
               -  Polymethylmethacrylate or other acrylates - at any time&#xD;
&#xD;
               -  Polyacrylamide - at any time&#xD;
&#xD;
               -  Polyethylene oxide - at any time&#xD;
&#xD;
               -  Polylactic acid - at any time&#xD;
&#xD;
               -  Liquid silicone - at any time&#xD;
&#xD;
               -  Other permanent implant material (FDA approved or not) - at any time&#xD;
&#xD;
          5. Subject has had the placement of any surgical implants in the NL folds region (e.g.,&#xD;
             Gortex, Silastic implants, thread lifts, etc.) at any time.&#xD;
&#xD;
          6. Subject has a history of multiple severe allergies or allergies manifested by&#xD;
             anaphylaxis.&#xD;
&#xD;
          7. Subject has a history of allergy to lidocaine.&#xD;
&#xD;
          8. Subject has a history of allergies to any bovine collagen products, including but not&#xD;
             limited to injectable collagen, collagen implants, hemostatic sponges, and&#xD;
             collagen-based sutures.&#xD;
&#xD;
          9. The subject has known hypersensitivity or previous allergic reaction to any of the&#xD;
             components of the study devices not previously mentioned.&#xD;
&#xD;
         10. Subject is undergoing or planning to undergo desensitization injections to meat&#xD;
             products.&#xD;
&#xD;
         11. Subject has any condition which, in the Investigator's opinion, would make it unsafe&#xD;
             for the subject to participate in this research study.&#xD;
&#xD;
         12. Subject is unable to communicate or cooperate with the Investigator due to language&#xD;
             problems, poor mental development, or impaired cerebral function.&#xD;
&#xD;
         13. Subject may be unreliable for the study including subjects who engage in excessive&#xD;
             alcohol intake or drug abuse, or subjects who are unable to return for scheduled&#xD;
             follow-up visits.&#xD;
&#xD;
             -&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <verification_date>October 2019</verification_date>
  <study_first_submitted>November 17, 2014</study_first_submitted>
  <study_first_submitted_qc>September 27, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">October 3, 2017</study_first_posted>
  <last_update_submitted>October 21, 2019</last_update_submitted>
  <last_update_submitted_qc>October 21, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">October 23, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Polymethyl Methacrylate</mesh_term>
  </intervention_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03299712
org study id: 521-01
nct id: NCT03299712
nct alias: NCT00778531
lead sponsor: 
has dmc: No
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.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Other
masking: None (Open Label)
measure: The incidence of granuloma formation.
time frame: 5 years
description: To determine the incidence of granuloma formation.
measure: Incidence of unanticipated adverse events
time frame: 5 years
description: 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.
measure: Incidence of anticipated adverse events
time frame: 5 years
description: The incidence of anticipated adverse events will be assessed at each follow-up visit.
measure: Assess of subject satisfaction
time frame: 5 years
description: 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.
arm group label: ArteFill
arm group type: Other
description: 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.
intervention type: Device
intervention name: ArteFill
description: soft tissue filler
arm group label: ArteFill
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
responsible party type: Sponsor
mesh term: Polymethyl Methacrylate