xml: <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/NCT05987319</url>
    </required_header>
    <id_info>
      <org_study_id>CYN20-RF-MN-02</org_study_id>
      <nct_id>NCT05987319</nct_id>
    </id_info>
    <brief_title>Feasibility Study to Collect and Assess Safety Data for a Radiofrequency Microneedling Device for Electrocoagulation and Hemostasis of Soft Tissues for Dermatologic Conditions</brief_title>
    <official_title>Feasibility Study to Collect and Assess Safety Data for a Radiofrequency Microneedling Device for Electrocoagulation and Hemostasis of Soft Tissues for Dermatologic Conditions.</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Cynosure, Inc.</agency>
        <agency_class>Industry</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Cynosure, 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_us_export>Yes</is_us_export>
    </oversight_info>
    <brief_summary>
      <textblock>
        The goal of the Potenza device used in this study is to collect clinical data for&#xD;
        dermatologic conditions in which electrocoagulation and hemostasis is a viable mechanism for&#xD;
        means of improvement.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Up to 12 subjects will be enrolled at 1 study center. Subjects will be enrolled into 2&#xD;
        groups. Group A will receive treatments on the face, neck, and/or body. Group B will receive&#xD;
        split-face treatments where each side of the face may be treated with different tips.&#xD;
        Subjects will attend a screening/pretreatment visit which may be performed on the same day as&#xD;
        the treatment visit. Subjects may receive up to 5 treatments.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">July 24, 2023</start_date>
    <completion_date type="Anticipated">April 2024</completion_date>
    <primary_completion_date type="Anticipated">April 2024</primary_completion_date>
    <phase>N/A</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>Non-Randomized</allocation>
      <intervention_model>Parallel Assignment</intervention_model>
      <primary_purpose>Treatment</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>% of subjects satisfied with treatments.</measure>
      <time_frame>30 days post last treatment</time_frame>
      <description>% of subjects satisfied with the treatment will the reported at the 30 days follow up.</description>
    </primary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">20</enrollment>
    <condition>Wrinkle</condition>
    <condition>Fine Lines</condition>
    <condition>Crepey Skin</condition>
    <condition>Acne Scars</condition>
    <condition>Active Acne</condition>
    <condition>Enlarged Pores</condition>
    <condition>Stretch Mark</condition>
    <condition>Loose Skin</condition>
    <arm_group>
      <arm_group_label>General Treatment</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Subjects will receive treatment on the face, neck and/or body for conditions such as but not limited to wrinkles, fine lines, crepey skin, acne scars, active acne, enlarged pores, stretch marks or loose skins.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Split-face treatment</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Subjects will receive split-face treatments where each side of the face may be treated with different tips.</description>
    </arm_group>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>RadioFrequency Microneedling Device</intervention_name>
      <description>RadioFrequency device will be used for the treatment of dermatologic conditions.</description>
      <arm_group_label>General Treatment</arm_group_label>
      <arm_group_label>Split-face treatment</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  A healthy, non-smoking male or female between the age of 22-65 years old.&#xD;
  &#xD;
            -  Fitzpatrick skin type I to VI.&#xD;
  &#xD;
            -  Understands and accepts obligation not to receive any other procedures on the&#xD;
               treatment area through the length of the study.&#xD;
  &#xD;
            -  Understands and accepts the obligation and is logistically able to be present for all&#xD;
               visits.&#xD;
  &#xD;
            -  Is willing to comply with all requirements of the study and sign the informed consent&#xD;
               document.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Is pregnant or of childbearing potential and not using medically effective birth&#xD;
               control, or has been pregnant in the last 3 months, currently breast feeding or&#xD;
               planning a pregnancy during the study.&#xD;
  &#xD;
            -  The subject is currently enrolled in an investigational drug or device trial or has&#xD;
               received an investigational drug or been treated with an investigational device within&#xD;
               in the area to be treated 1 month prior to entering this study.&#xD;
  &#xD;
            -  The subject has a pacemaker.&#xD;
  &#xD;
            -  The subject had previous use of gold thread skin rejuvenation.&#xD;
  &#xD;
            -  The subject has a cut, wound, or infected skin on the area to be treated (but skin&#xD;
               eruptions may be treated).&#xD;
  &#xD;
            -  The subject has a metal implant that interferes with the transmission of energy to the&#xD;
               electrical field.&#xD;
  &#xD;
            -  The subject has any embedded electronic devices that give or receive a signal.&#xD;
  &#xD;
            -  The subject has Implantable Cardiac Defibrillators (ICD) or Cardiac Resynchronization&#xD;
               Therapy (CRT) devices: treatment may interfere with the functionality of the device&#xD;
               and/or damage the electronic implant.&#xD;
  &#xD;
            -  The subject is allergic to adhesives such as glues on medical tape: they should be&#xD;
               alerted that a rash may occur on the neutral electronic monitoring pad (NEM or neutral&#xD;
               pad) site, and an over-the-counter preparation may be used to treat the area.&#xD;
  &#xD;
            -  The subject is allergic to gold.&#xD;
  &#xD;
            -  The subject has an unrealistic expectation of the results: this is not plastic&#xD;
               surgery, and all subjects should be fully informed of the treatment's expected&#xD;
               results.&#xD;
  &#xD;
            -  The subject has nerve insensitivity to heat in the treatment area or in the neutral&#xD;
               pad placement area.&#xD;
  &#xD;
            -  The subject has severe laxity or sagging that causes redundant folds of tissue or&#xD;
               hanging skin in the area to be treated: this treatment will be ineffective.&#xD;
  &#xD;
            -  The subject has used Accutane (isotretinoin) six to twelve months prior to treatment,&#xD;
               as this can thin the skin and make it brittle.&#xD;
  &#xD;
            -  The subject is taking aspirin or are currently taking antiplatelets, thrombolytics,&#xD;
               anti- inflammatories or anticoagulants.&#xD;
  &#xD;
            -  The subject has a history of bleeding coagulopathies.&#xD;
  &#xD;
            -  The subject is allergic to topical anesthetic.&#xD;
  &#xD;
            -  The subject has any of the following conditions:&#xD;
  &#xD;
                 -  Diabetes&#xD;
  &#xD;
                 -  Epilepsy&#xD;
  &#xD;
                 -  Autoimmune disease&#xD;
  &#xD;
                 -  Herpes simplex&#xD;
  &#xD;
                 -  HIV&#xD;
  &#xD;
                 -  Hypertension&#xD;
  &#xD;
                 -  Dermatitis&#xD;
  &#xD;
            -  The subject has keloid formation propensity.&#xD;
  &#xD;
            -  Subjects with electronic implants such as cardiac defibrillator. It may interfere with&#xD;
               operation of electronic implants or damage the implants, causing risks.&#xD;
  &#xD;
            -  The subject has any condition or is in a situation which in the investigator's opinion&#xD;
               may put the subject at significant risk, may confound study results or may interfere.&#xD;
  &#xD;
          significantly with the subject's participation.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>22 Years</minimum_age>
      <maximum_age>65 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_contact>
      <last_name>Jamie Trimper</last_name>
      <phone>9782564200</phone>
      <email>jamie.trimper@cynosure.com</email>
    </overall_contact>
    <location>
      <facility>
        <name>Cynosure, Inc.</name>
        <address>
          <city>Westford</city>
          <state>Massachusetts</state>
          <zip>01886</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Sean Doherty</last_name>
      </contact>
      <investigator>
        <last_name>Sean Doherty</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location_countries>
      <country>United States</country>
    </location_countries>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>August 3, 2023</study_first_submitted>
    <study_first_submitted_qc>August 3, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 14, 2023</study_first_posted>
    <last_update_submitted>September 6, 2023</last_update_submitted>
    <last_update_submitted_qc>September 6, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 8, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Skin Diseases</mesh_term>
      <mesh_term>Striae Distensae</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT05987319
  org study id: CYN20-RF-MN-02
  nct id: NCT05987319
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: Yes
  is us export: Yes
  The goal of the Potenza device used in this study is to collect clinical data for
        dermatologic conditions in which electrocoagulation and hemostasis is a viable mechanism for
        means of improvement.
  Up to 12 subjects will be enrolled at 1 study center. Subjects will be enrolled into 2
        groups. Group A will receive treatments on the face, neck, and/or body. Group B will receive
        split-face treatments where each side of the face may be treated with different tips.
        Subjects will attend a screening/pretreatment visit which may be performed on the same day as
        the treatment visit. Subjects may receive up to 5 treatments.
  allocation: Non-Randomized
  intervention model: Parallel Assignment
  primary purpose: Treatment
  masking: None (Open Label)
  measure: % of subjects satisfied with treatments.
  time frame: 30 days post last treatment
  description: % of subjects satisfied with the treatment will the reported at the 30 days follow up.
  arm group label: General Treatment
  arm group type: Experimental
  description: Subjects will receive treatment on the face, neck and/or body for conditions such as but not limited to wrinkles, fine lines, crepey skin, acne scars, active acne, enlarged pores, stretch marks or loose skins.
  arm group label: Split-face treatment
  arm group type: Experimental
  description: Subjects will receive split-face treatments where each side of the face may be treated with different tips.
  intervention type: Device
  intervention name: RadioFrequency Microneedling Device
  description: RadioFrequency device will be used for the treatment of dermatologic conditions.
  arm group label: General Treatment
  arm group label: Split-face treatment
  criteria: 
  gender: All
  minimum age: 22 Years
  maximum age: 65 Years
  healthy volunteers: No
  last name: Jamie Trimper
  phone: 9782564200
  email: jamie.trimper@cynosure.com
  facility: 
  status: Recruiting
  contact: 
  investigator: 
  country: United States
  responsible party type: Sponsor
  mesh term: Skin Diseases
  mesh term: Striae Distensae
  sharing ipd: No