<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/NCT03782038</url>
  </required_header>
  <id_info>
    <org_study_id>AIS 700-00053</org_study_id>
    <nct_id>NCT03782038</nct_id>
  </id_info>
  <brief_title>Study to Evaluate the Efficacy of a Micro Coring Device for the Treatment of Scars of the Cytrellis Micro-Coring Device for the Treatment of Scars</brief_title>
  <official_title>A Prospective, Multi-center, Pilot Study to Evaluate the Safety and Efficacy of the Cytrellis Micro-Coring Device for the Treatment of Scars</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Cytrellis Biosystems, Inc.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Cytrellis Biosystems, Inc.</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>Yes</is_fda_regulated_device>
    <is_unapproved_device>Yes</is_unapproved_device>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      A study to evaluate the safety and effectiveness of a micro coring device for the treatment&#xD;
      of scars.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The study subject population will consist to up to 30 subjects who meet the&#xD;
      inclusion/exclusion criteria. All subjects will be monitored for a period of 6 months post&#xD;
      last treatment.&#xD;
&#xD;
      An study results will be assessed on the following:&#xD;
&#xD;
        -  POSAS - Patient Observer Scar Assessment&#xD;
&#xD;
        -  ASAS - Acne Scar Severity Scale&#xD;
&#xD;
        -  Subject Satisfaction Scale&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">September 13, 2018</start_date>
  <completion_date type="Anticipated">November 21, 2019</completion_date>
  <primary_completion_date type="Anticipated">September 17, 2019</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>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Assess level of aesthetic improvement using POSAS scale 6 months post last treatment</measure>
    <time_frame>6 months post last treatment</time_frame>
    <description>Assessing the improvement in the aesthetic appearance of the subject based on the POSAS scale comparing baseline to 6 months post last treatment. Parameters of vascularity, pigmentation, thickness, relief, and pliability, range from 1 to 10. normal skin =1; worst scar imaginable =10.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Assess level of aesthetic improvement using ASAS scale 6 months post last treatment</measure>
    <time_frame>6 months post last treatment</time_frame>
    <description>Assessing the improvement in the aesthetic appearance of the subject based on the Acne Scar scale comparing baseline to 6 months post last treatment. Grades range 0-4. Clear =0; Very Mild=1; Mild= 2; Moderate= 3; Severe= 4</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Assess safety profile by recording all adverse events reported during study</measure>
    <time_frame>6 months post last treatment</time_frame>
    <description>Adverse events will be recorded throughout the study</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">30</enrollment>
  <condition>Scars</condition>
  <arm_group>
    <arm_group_label>Micro-coring of scars with MCD</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Micro coring of acne scars and straie will be conducted in up to 3 treatments and followed 6 months post last treatment with MCD.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>MCD</intervention_name>
    <description>Micro coring skin removal with automated coring device</description>
    <arm_group_label>Micro-coring of scars with MCD</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  18 years of age or older&#xD;
&#xD;
          -  Fitzpatrick scale I-VI.&#xD;
&#xD;
          -  Any type of scar except for keloid scars&#xD;
&#xD;
          -  Able to provide written informed consent, understand and willing to comply with study&#xD;
             related procedures and follow-ups.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Previous treatment of the scar tissue within last 6 months.&#xD;
&#xD;
          -  Silicone, fat, collagen or synthetic material in the treatment area.&#xD;
&#xD;
          -  History of keloid formation.&#xD;
&#xD;
          -  Active smokers (smoking more than ½ pack per day) or having quit smoking (½ pack per&#xD;
             day) for less than 3 months.&#xD;
&#xD;
          -  Active, chronic, or recurrent infection.&#xD;
&#xD;
          -  Compromised immune system (e.g. diabetes).&#xD;
&#xD;
          -  Hypersensitivity to analgesic agents.&#xD;
&#xD;
          -  Co-morbid condition that could limit ability to participate in the study or to comply&#xD;
             with follow-up requirements.&#xD;
&#xD;
          -  Pregnant or breastfeeding.&#xD;
&#xD;
          -  Any issue that, at the discretion of the investigator, would contra-indicate the&#xD;
             subject's participation.&#xD;
&#xD;
          -  Any medication that may cause bleeding such as anticoagulants.&#xD;
&#xD;
          -  Allergy to lidocaine and/or epinephrine&#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>
  <location>
    <facility>
      <name>Miami Dermatology &amp; Laser Institute</name>
      <address>
        <city>Miami</city>
        <state>Florida</state>
        <zip>33173</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Nicole Rieth</last_name>
      <phone>305-279-6060</phone>
      <email>nicoler@miamidermlaser.com</email>
    </contact>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>December 2018</verification_date>
  <study_first_submitted>December 18, 2018</study_first_submitted>
  <study_first_submitted_qc>December 18, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 20, 2018</study_first_posted>
  <last_update_submitted>December 19, 2018</last_update_submitted>
  <last_update_submitted_qc>December 19, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">December 21, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Acne Scars</keyword>
  <keyword>Stretchmarks</keyword>
  <keyword>Surgical Scars</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Cicatrix</mesh_term>
  </condition_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/NCT03782038
org study id: AIS 700-00053
nct id: NCT03782038
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: Yes
is unapproved device: Yes
is us export: No
A study to evaluate the safety and effectiveness of a micro coring device for the treatment
      of scars.
The study subject population will consist to up to 30 subjects who meet the
      inclusion/exclusion criteria. All subjects will be monitored for a period of 6 months post
      last treatment.

      An study results will be assessed on the following:

        -  POSAS - Patient Observer Scar Assessment

        -  ASAS - Acne Scar Severity Scale

        -  Subject Satisfaction Scale
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Assess level of aesthetic improvement using POSAS scale 6 months post last treatment
time frame: 6 months post last treatment
description: Assessing the improvement in the aesthetic appearance of the subject based on the POSAS scale comparing baseline to 6 months post last treatment. Parameters of vascularity, pigmentation, thickness, relief, and pliability, range from 1 to 10. normal skin =1; worst scar imaginable =10.
measure: Assess level of aesthetic improvement using ASAS scale 6 months post last treatment
time frame: 6 months post last treatment
description: Assessing the improvement in the aesthetic appearance of the subject based on the Acne Scar scale comparing baseline to 6 months post last treatment. Grades range 0-4. Clear =0; Very Mild=1; Mild= 2; Moderate= 3; Severe= 4
measure: Assess safety profile by recording all adverse events reported during study
time frame: 6 months post last treatment
description: Adverse events will be recorded throughout the study
arm group label: Micro-coring of scars with MCD
arm group type: Experimental
description: Micro coring of acne scars and straie will be conducted in up to 3 treatments and followed 6 months post last treatment with MCD.
intervention type: Device
intervention name: MCD
description: Micro coring skin removal with automated coring device
arm group label: Micro-coring of scars with MCD
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
facility: 
status: Recruiting
contact: 
country: United States
responsible party type: Sponsor
mesh term: Cicatrix