<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/NCT04480645</url>
  </required_header>
  <id_info>
    <org_study_id>CT008</org_study_id>
    <nct_id>NCT04480645</nct_id>
  </id_info>
  <brief_title>CivaDerm(TM) Surface Therapy Pilot Study</brief_title>
  <official_title>CivaDerm(TM) Surface Therapy Pilot Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>CivaTech Oncology</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>CivaTech Oncology</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>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      This is a pilot study to determine the usefulness of new brachytherapy device that utilizes&#xD;
      active components (palladium-103) of standard devices in a novel configuration, which may&#xD;
      benefit basal cell and squamous cell carcinoma patients by providing conformal radiation&#xD;
      therapy to the surface of the skin.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Not yet recruiting</overall_status>
  <start_date type="Anticipated">October 1, 2022</start_date>
  <completion_date type="Anticipated">April 30, 2023</completion_date>
  <primary_completion_date type="Anticipated">February 1, 2023</primary_completion_date>
  <phase>Early Phase 1</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>
    <intervention_model_description>Single arm pilot study</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>skin toxicity events</measure>
    <time_frame>within 2 months of treatment</time_frame>
    <description>grade 3+ events</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>dose delivered to target</measure>
    <time_frame>1 week</time_frame>
    <description>calculated radiation dose</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">10</enrollment>
  <condition>Basal Cell Carcinoma</condition>
  <condition>Squamous Cell Carcinoma of the Skin</condition>
  <arm_group>
    <arm_group_label>Treatment</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Radioactive bandage applied to surface of the body worn for approximately one week.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>CivaDerm</intervention_name>
    <description>radioactive bandage</description>
    <arm_group_label>Treatment</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  subject signed informed consent&#xD;
&#xD;
          -  Confirmed superficial or nodular basal cell or squamous cell carcinoma&#xD;
&#xD;
          -  Biopsy proven on chest, stomach, back, arms, legs, feet (trunk and extremities)&#xD;
&#xD;
          -  &gt;5 mm of residual tumor&#xD;
&#xD;
          -  tumors &lt; 3 cm&#xD;
&#xD;
          -  Capable of complying with Patient Release Instructions&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Is unable or unwilling to comply with the protocol requirements&#xD;
&#xD;
          -  Pregnant or breast feeding&#xD;
&#xD;
          -  Metastases&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Kristy Perez, PhD</last_name>
    <phone>9193145515</phone>
    <email>kperez@civatechoncology.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Carra Castagnero</last_name>
    <phone>9193145515</phone>
    <email>clinical@civatechoncology.com</email>
  </overall_contact_backup>
  <verification_date>July 2022</verification_date>
  <study_first_submitted>July 16, 2020</study_first_submitted>
  <study_first_submitted_qc>July 20, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 21, 2020</study_first_posted>
  <last_update_submitted>July 18, 2022</last_update_submitted>
  <last_update_submitted_qc>July 18, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">July 19, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>radiation</keyword>
  <keyword>brachytherapy</keyword>
  <keyword>skin cancer</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Carcinoma</mesh_term>
    <mesh_term>Carcinoma, Basal Cell</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- 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/NCT04480645
org study id: CT008
nct id: NCT04480645
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: Yes
is us export: No
This is a pilot study to determine the usefulness of new brachytherapy device that utilizes
      active components (palladium-103) of standard devices in a novel configuration, which may
      benefit basal cell and squamous cell carcinoma patients by providing conformal radiation
      therapy to the surface of the skin.
allocation: N/A
intervention model: Single Group Assignment
intervention model description: Single arm pilot study
primary purpose: Treatment
masking: None (Open Label)
measure: skin toxicity events
time frame: within 2 months of treatment
description: grade 3+ events
measure: dose delivered to target
time frame: 1 week
description: calculated radiation dose
arm group label: Treatment
arm group type: Experimental
description: Radioactive bandage applied to surface of the body worn for approximately one week.
intervention type: Device
intervention name: CivaDerm
description: radioactive bandage
arm group label: Treatment
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Kristy Perez, PhD
phone: 9193145515
email: kperez@civatechoncology.com
last name: Carra Castagnero
phone: 9193145515
email: clinical@civatechoncology.com
responsible party type: Sponsor
mesh term: Carcinoma
mesh term: Carcinoma, Basal Cell
sharing ipd: No