<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/NCT02221128</url>
  </required_header>
  <id_info>
    <org_study_id>PCT1402.001M(06/14)</org_study_id>
    <nct_id>NCT02221128</nct_id>
  </id_info>
  <brief_title>PerClot to Control Bleeding in Endoscopic Sinus Surgery</brief_title>
  <official_title>A Post Market Surveillance Study Evaluating the Safety and Effectiveness of PerClot to Control Mild Bleeding in Subjects Undergoing Endoscopic Sinus Surgery</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>CryoLife Europa</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>CryoLife, Inc.</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>CryoLife Europa</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      A prospective, single centre, single arm study designed to collect clinical data on PerClot&#xD;
      when used in subjects undergoing endoscopic sinus surgery.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>July 2014</start_date>
  <completion_date type="Actual">September 2014</completion_date>
  <primary_completion_date type="Actual">September 2014</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Only</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Number of subjects who achieve of haemostasis after the application of PerClot</measure>
    <time_frame>intraoperatively</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Number of subjects who require the use of alternative methods to achieve haemostasis after the application of PerClot</measure>
    <time_frame>intraoperatively</time_frame>
  </secondary_outcome>
  <enrollment type="Actual">12</enrollment>
  <condition>Sinusitis</condition>
  <eligibility>
    <study_pop>
      <textblock>
        Adults undergoing Endoscopic Sinus Surgery&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Subjects having Endoscopic Sinus Surgery&#xD;
&#xD;
          -  Subjects who will have PerClot used as a haemostatic agent&#xD;
&#xD;
          -  Subjects willing and able to give consent&#xD;
&#xD;
          -  Subjects over 18 years old&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Subjects unable or unwilling to give consent for their data to be collected&#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_official>
    <last_name>David Roberts</last_name>
    <role>Principal Investigator</role>
    <affiliation>Guy's and St Thomas' NHS Foundation Trust</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Guys and St Thomas NHS Trust</name>
      <address>
        <city>London</city>
        <zip>SE1 9RT</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United Kingdom</country>
  </location_countries>
  <verification_date>July 2014</verification_date>
  <study_first_submitted>July 3, 2014</study_first_submitted>
  <study_first_submitted_qc>August 19, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 20, 2014</study_first_posted>
  <last_update_submitted>October 2, 2014</last_update_submitted>
  <last_update_submitted_qc>October 2, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">October 3, 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>Sinusitis</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/NCT02221128
org study id: PCT1402.001M(06/14)
nct id: NCT02221128
lead sponsor: 
collaborator: 
has dmc: No
A prospective, single centre, single arm study designed to collect clinical data on PerClot
      when used in subjects undergoing endoscopic sinus surgery.
observational model: Case-Only
time perspective: Prospective
measure: Number of subjects who achieve of haemostasis after the application of PerClot
time frame: intraoperatively
measure: Number of subjects who require the use of alternative methods to achieve haemostasis after the application of PerClot
time frame: intraoperatively
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: David Roberts
role: Principal Investigator
affiliation: Guy's and St Thomas' NHS Foundation Trust
facility: 
country: United Kingdom
responsible party type: Sponsor
mesh term: Sinusitis