<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/NCT01706861</url>
  </required_header>
  <id_info>
    <org_study_id>HAL-302</org_study_id>
    <nct_id>NCT01706861</nct_id>
  </id_info>
  <brief_title>A Post Market Study Evaluating the Safety, Device Perfomance and Possible Emergent Risks of Celotres in Preventing Recurrence in Keloid Lesions Treated Adjunctive to Surgical Excision</brief_title>
  <acronym>EURO KLEAR</acronym>
  <official_title>A Post Market Study Evaluating the Safety, Device Perfomance and Possible Emergent Risks of Celotres in Preventing Recurrence in Keloid LEsions Treated Adjunctive to suRgical Excision. PMCS: EURO-KLEAR</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Halscion, Inc.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Halscion, Inc.</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The objective of the study is to actively gather additional information on safety, device&#xD;
      performance and possible emergent risks following the use of Celotres in a post-market&#xD;
      setting when used to reduce the recurrence rate, volume, appearance and/or symptoms&#xD;
      associated with keloid scarring in subjects undergoing surgical excision of keloids as&#xD;
      compared to the scientific literature.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>September 2012</start_date>
  <completion_date type="Actual">May 2014</completion_date>
  <primary_completion_date type="Actual">May 2014</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>The incidence of device related adverse events</measure>
    <time_frame>Assessed at treatment, suture removal, Months 1, 3, 6, 9 and 12</time_frame>
    <description>Device safety is defined as the incidence of device related adverse events.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Recurrence of keloid post scar excision</measure>
    <time_frame>Assessed at 1, 3, 6, 9 and 12 months</time_frame>
    <description>Proportion of subjects with recurrence of keloid scar post excision defined as the presence of scar tissue volume &gt;0.3cc</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Patient and Observer Scar Assessment Scale (POSAS)</measure>
    <time_frame>Assessed at Pre-treatment, Months 1, 3, 6, 9 and 12</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Subject Dermatology Life Quality Index (DLQI)</measure>
    <time_frame>Assessed at Pre-treatment, Months 1, 3, 6, 9 and 12</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Device Performance Evaluation</measure>
    <time_frame>Assessed at Day 1</time_frame>
    <description>Questions related to packaging integrity and successful administration of product as assessed by the Principal Investigator.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">51</enrollment>
  <condition>Earlobe Keloids</condition>
  <arm_group>
    <arm_group_label>Celotres</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Celotres following surgical removal of earlobe keloid.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Celotres</intervention_name>
    <description>Celotres following surgical removal of earlobe keloid.</description>
    <arm_group_label>Celotres</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients electing to undergo keloid excision procedure&#xD;
&#xD;
          -  Patients able and willing to give written informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients with a known or potential risk of allergy or sensitivity to products or&#xD;
             substances containing porcine gelatin.&#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>
  <overall_official>
    <last_name>Sam Bella, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>The Westbourne Centre</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of the West Indies</name>
      <address>
        <city>Nassau</city>
        <country>Bahamas</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Angelius Szpital Proviat</name>
      <address>
        <city>Katowice</city>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Oddzial Leczenia Oparzen Chirugil Plastysznej</name>
      <address>
        <city>Krakow</city>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Kosmetyczno-Lekarska Spółdzielnia Pracy &quot;IZIS&quot;</name>
      <address>
        <city>Warsaw</city>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Wojskowy Oddzial Kliniczny ChirurgiiPlastycznej</name>
      <address>
        <city>Warsaw</city>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The Westbourne Centre</name>
      <address>
        <city>Edgbaston</city>
        <state>Birmingham</state>
        <zip>B15 3SJ</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Bahamas</country>
    <country>Poland</country>
    <country>United Kingdom</country>
  </location_countries>
  <verification_date>February 2014</verification_date>
  <study_first_submitted>October 3, 2012</study_first_submitted>
  <study_first_submitted_qc>October 12, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 15, 2012</study_first_posted>
  <last_update_submitted>May 24, 2014</last_update_submitted>
  <last_update_submitted_qc>May 24, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">May 28, 2014</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>Keloid</mesh_term>
    <mesh_term>Recurrence</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/NCT01706861
org study id: HAL-302
nct id: NCT01706861
lead sponsor: 
has dmc: No
The objective of the study is to actively gather additional information on safety, device
      performance and possible emergent risks following the use of Celotres in a post-market
      setting when used to reduce the recurrence rate, volume, appearance and/or symptoms
      associated with keloid scarring in subjects undergoing surgical excision of keloids as
      compared to the scientific literature.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: The incidence of device related adverse events
time frame: Assessed at treatment, suture removal, Months 1, 3, 6, 9 and 12
description: Device safety is defined as the incidence of device related adverse events.
measure: Recurrence of keloid post scar excision
time frame: Assessed at 1, 3, 6, 9 and 12 months
description: Proportion of subjects with recurrence of keloid scar post excision defined as the presence of scar tissue volume >0.3cc
measure: Patient and Observer Scar Assessment Scale (POSAS)
time frame: Assessed at Pre-treatment, Months 1, 3, 6, 9 and 12
measure: Subject Dermatology Life Quality Index (DLQI)
time frame: Assessed at Pre-treatment, Months 1, 3, 6, 9 and 12
measure: Device Performance Evaluation
time frame: Assessed at Day 1
description: Questions related to packaging integrity and successful administration of product as assessed by the Principal Investigator.
arm group label: Celotres
arm group type: Other
description: Celotres following surgical removal of earlobe keloid.
intervention type: Device
intervention name: Celotres
description: Celotres following surgical removal of earlobe keloid.
arm group label: Celotres
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Sam Bella, MD
role: Principal Investigator
affiliation: The Westbourne Centre
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
country: Bahamas
country: Poland
country: United Kingdom
responsible party type: Sponsor
mesh term: Keloid
mesh term: Recurrence