<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/NCT02225080</url>
  </required_header>
  <id_info>
    <org_study_id>N-DURSEC-001</org_study_id>
    <nct_id>NCT02225080</nct_id>
  </id_info>
  <brief_title>Duragen® Secure Post Marketing Clinical Follow-up (PMCF)</brief_title>
  <official_title>Duragen® Secure Post Marketing Clinical Follow-up (PMCF)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Integra LifeSciences Corporation</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Integra LifeSciences Corporation</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to gather information about post-market performance of DuraGen&#xD;
      Secure.The aim of this post market clinical follow-up (PMCF) is to obtain post market&#xD;
      clinical data to evaluate the presence of unintended residual risks associated with the use&#xD;
      of DuraGen Secure that were not anticipated or identified in the animal studies, bench&#xD;
      studies or clinical evaluation report.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>October 2014</start_date>
  <completion_date type="Actual">June 2016</completion_date>
  <primary_completion_date type="Actual">June 2016</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>Retrospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Patient's Outcome</measure>
    <time_frame>Day 30</time_frame>
    <description>Patient outcome from the procedure (recovered without sequelae, ongoing with medical intervention, ongoing with surgical intervention, deceased, other)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Occurence of Adverse Event</measure>
    <time_frame>first 72 hours post-op</time_frame>
    <description>Adverse event that occured 72 hours post-operatively</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Occurence of Adverse Event</measure>
    <time_frame>between days 4-14</time_frame>
    <description>Adverse event that occured between days 4-14 post-operatively</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Occurence of Adverse Event</measure>
    <time_frame>Between days 15-30</time_frame>
    <description>Adverse event that occured between days 15-30 post-operatively</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">100</enrollment>
  <condition>Dura Mater Nick Cut or Tear</condition>
  <condition>Surgery</condition>
  <arm_group>
    <arm_group_label>Duragen Secure</arm_group_label>
    <description>Have undergone a neurosurgical procedure where DuraGen® Secure has been implanted</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        Neurgosurgery service in Hospital&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patient who have undergone a neurosurgical procedure where DuraGen® Secure has been&#xD;
             implanted&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patient who does not agree to allow collection of his/her medical data&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Hopital Lariboisière</name>
      <address>
        <city>Paris</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>die Charité - Universitätsmedizin Berlin</name>
      <address>
        <city>Berlin</city>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Universitario 12 de Octubre</name>
      <address>
        <city>Madrid</city>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Universitario La Fe</name>
      <address>
        <city>Valencia</city>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>National Hospital for Neurology and Neurosurgery</name>
      <address>
        <city>London</city>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
    <country>Germany</country>
    <country>Spain</country>
    <country>United Kingdom</country>
  </location_countries>
  <verification_date>September 2018</verification_date>
  <study_first_submitted>July 28, 2014</study_first_submitted>
  <study_first_submitted_qc>August 22, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 25, 2014</study_first_posted>
  <results_first_submitted>November 15, 2017</results_first_submitted>
  <results_first_submitted_qc>November 15, 2017</results_first_submitted_qc>
  <results_first_posted type="Actual">August 16, 2018</results_first_posted>
  <last_update_submitted>September 10, 2018</last_update_submitted>
  <last_update_submitted_qc>September 10, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">October 9, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Duragen Secure</title>
          <description>Have undergone a neurosurgical procedure where DuraGen® Secure has been implanted</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="100"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="100"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Duragen Secure</title>
          <description>Have undergone a neurosurgical procedure where DuraGen® Secure has been implanted</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="100"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="100"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="53.1" spread="14.76"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="100"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="57"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="43"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race and Ethnicity Not Collected</title>
          <population>Race and Ethnicity were not collected from any participant.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Patient's Outcome</title>
        <description>Patient outcome from the procedure (recovered without sequelae, ongoing with medical intervention, ongoing with surgical intervention, deceased, other)</description>
        <time_frame>Day 30</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Duragen Secure</title>
            <description>Have undergone a neurosurgical procedure where DuraGen® Secure has been implanted</description>
          </group>
        </group_list>
        <measure>
          <title>Patient's Outcome</title>
          <description>Patient outcome from the procedure (recovered without sequelae, ongoing with medical intervention, ongoing with surgical intervention, deceased, other)</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="100"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Recovered without sequelae</title>
                  <measurement_list>
                    <measurement group_id="O1" value="73"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Ongoing with medical intervention</title>
                  <measurement_list>
                    <measurement group_id="O1" value="7"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Ongoing with surgical intervention</title>
                  <measurement_list>
                    <measurement group_id="O1" value="15"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Deceased</title>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Other</title>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Occurence of Adverse Event</title>
        <description>Adverse event that occured 72 hours post-operatively</description>
        <time_frame>first 72 hours post-op</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Duragen Secure</title>
            <description>Have undergone a neurosurgical procedure where DuraGen® Secure has been implanted</description>
          </group>
        </group_list>
        <measure>
          <title>Occurence of Adverse Event</title>
          <description>Adverse event that occured 72 hours post-operatively</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="100"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="19"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Occurence of Adverse Event</title>
        <description>Adverse event that occured between days 4-14 post-operatively</description>
        <time_frame>between days 4-14</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Duragen Secure</title>
            <description>Have undergone a neurosurgical procedure where DuraGen® Secure has been implanted</description>
          </group>
        </group_list>
        <measure>
          <title>Occurence of Adverse Event</title>
          <description>Adverse event that occured between days 4-14 post-operatively</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="100"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="18"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Occurence of Adverse Event</title>
        <description>Adverse event that occured between days 15-30 post-operatively</description>
        <time_frame>Between days 15-30</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Duragen Secure</title>
            <description>Have undergone a neurosurgical procedure where DuraGen® Secure has been implanted</description>
          </group>
        </group_list>
        <measure>
          <title>Occurence of Adverse Event</title>
          <description>Adverse event that occured between days 15-30 post-operatively</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="100"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="15"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Retrospective chart review of AE occured between surgery (Day 0) and file completion (between Day 30 and Day 60)</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Duragen Secure</title>
          <description>Have undergone a neurosurgical procedure where DuraGen® Secure has been implanted</description>
        </group>
      </group_list>
      <serious_events>
        <default_vocab>MedDRA (17.1)</default_vocab>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="100"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="31" subjects_at_risk="100"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Blood and lymphatic system disorders</title>
            <event_list>
              <event>
                <sub_title>Anemia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="100"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>Cardiac arrhythmia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="100"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Dysphagia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="100"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Inflammatory reaction</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="100"/>
              </event>
              <event>
                <sub_title>Wound healing disturbance</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="100"/>
              </event>
              <event>
                <sub_title>Death</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="100"/>
              </event>
              <event>
                <sub_title>Weakness worsened</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="100"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Infection</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="100"/>
              </event>
              <event>
                <sub_title>Meningitis</sub_title>
                <counts group_id="E1" subjects_affected="5" subjects_at_risk="100"/>
              </event>
              <event>
                <sub_title>subdural empyema</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="100"/>
              </event>
              <event>
                <sub_title>Shunt infection</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="100"/>
              </event>
              <event>
                <sub_title>cerebral empyema</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="100"/>
              </event>
              <event>
                <sub_title>Septic shock</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="100"/>
              </event>
              <event>
                <sub_title>Pneumonia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="100"/>
              </event>
              <event>
                <sub_title>Bronchopneumonia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="100"/>
              </event>
              <event>
                <sub_title>Bladder infection</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="100"/>
              </event>
              <event>
                <sub_title>Wound Infection</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="100"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Anemia postoperative</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="100"/>
              </event>
              <event>
                <sub_title>Postoperative bleeding</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="100"/>
              </event>
              <event>
                <sub_title>Graft failure</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="100"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Investigations</title>
            <event_list>
              <event>
                <sub_title>Cardiac enzymes increased</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="100"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Neoplasms benign, malignant and unspecified (incl cysts and polyps)</title>
            <event_list>
              <event>
                <sub_title>Lung cancer</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="100"/>
              </event>
              <event>
                <sub_title>Neoplasm recurrence</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="100"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>CSF leakage</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="100"/>
              </event>
              <event>
                <sub_title>Haematoma cerebral</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="100"/>
              </event>
              <event>
                <sub_title>Intracranial haemorrhage</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="100"/>
              </event>
              <event>
                <sub_title>Seizure</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="100"/>
              </event>
              <event>
                <sub_title>Subdural Hygroma</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="100"/>
              </event>
              <event>
                <sub_title>Hydrocephalus</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="100"/>
              </event>
              <event>
                <sub_title>Paraparesis</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="100"/>
              </event>
              <event>
                <sub_title>Hemiparesis</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="100"/>
              </event>
              <event>
                <sub_title>Hemorrhage intracranial</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="100"/>
              </event>
              <event>
                <sub_title>Intracranial hypertension</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="100"/>
              </event>
              <event>
                <sub_title>Dysarthria</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="100"/>
              </event>
              <event>
                <sub_title>Cerebrospinal fluid leakage</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="100"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Psychiatric disorders</title>
            <event_list>
              <event>
                <sub_title>Organic brain syndrome</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="100"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Renal and urinary disorders</title>
            <event_list>
              <event>
                <sub_title>Renal insufficiency</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="100"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Pulmonary embolism</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="100"/>
              </event>
              <event>
                <sub_title>Lung edema</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="100"/>
              </event>
              <event>
                <sub_title>Pleural effusion</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="100"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Surgical and medical procedures</title>
            <event_list>
              <event>
                <sub_title>Brain tumor operation</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="100"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Vascular disorders</title>
            <event_list>
              <event>
                <sub_title>Thrombosis venous deep</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="100"/>
              </event>
              <event>
                <sub_title>Haemorrhage</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="100"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>5</frequency_threshold>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="100"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.</restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Director, Global Clinical Affairs</name_or_title>
      <organization>Integra LifeSciences Corporation</organization>
      <phone>609-936-5490</phone>
      <email>andrew.tummon@integralife.com</email>
    </point_of_contact>
  </clinical_results>
</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/NCT02225080
org study id: N-DURSEC-001
nct id: NCT02225080
lead sponsor: 
has dmc: No
The purpose of this study is to gather information about post-market performance of DuraGen
      Secure.The aim of this post market clinical follow-up (PMCF) is to obtain post market
      clinical data to evaluate the presence of unintended residual risks associated with the use
      of DuraGen Secure that were not anticipated or identified in the animal studies, bench
      studies or clinical evaluation report.
observational model: Case-Only
time perspective: Retrospective
measure: Patient's Outcome
time frame: Day 30
description: Patient outcome from the procedure (recovered without sequelae, ongoing with medical intervention, ongoing with surgical intervention, deceased, other)
measure: Occurence of Adverse Event
time frame: first 72 hours post-op
description: Adverse event that occured 72 hours post-operatively
measure: Occurence of Adverse Event
time frame: between days 4-14
description: Adverse event that occured between days 4-14 post-operatively
measure: Occurence of Adverse Event
time frame: Between days 15-30
description: Adverse event that occured between days 15-30 post-operatively
arm group label: Duragen Secure
description: Have undergone a neurosurgical procedure where DuraGen® Secure has been implanted
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: No
facility: 
facility: 
facility: 
facility: 
facility: 
country: France
country: Germany
country: Spain
country: United Kingdom
responsible party type: Sponsor
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 