<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/NCT04490629</url>
  </required_header>
  <id_info>
    <org_study_id>2017-126</org_study_id>
    <nct_id>NCT04490629</nct_id>
  </id_info>
  <brief_title>The Efficacy and Safety of a Latest Dural Substitute</brief_title>
  <acronym>ESLO</acronym>
  <official_title>A Prospective, Multi-center, Randomized, Parallel-controlled Clinical Trial Evaluating the Efficacy and Safety of Lyoplant Onlay in Repairing Cerebral Dura Mater</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Second Affiliated Hospital, School of Medicine, Zhejiang University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Second Affiliated Hospital, School of Medicine, Zhejiang University</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This prospective, multi-center, randomized, parallel-controlled clinical trial was designed&#xD;
      to evaluate the efficacy and safety of Lyoplant Onlay in repairing cerebral dura mater.&#xD;
      DURAFORM was regarded as the control group. a total of 80 patients were randomized into&#xD;
      experimental and control group (1:1).Data were collected on complications resulting in CSF&#xD;
      leaks, surgical site infections, instrument performance parameterized other neurological&#xD;
      complications within 30 days. Surgeons also provided data on the ease of use of the dural&#xD;
      sealing techniques, as well as preparation and application times. The above-mentioned date&#xD;
      were used to evaluate the efficacy and safety of Lyoplant Onlay .&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">November 1, 2019</start_date>
  <completion_date type="Anticipated">November 1, 2021</completion_date>
  <primary_completion_date type="Anticipated">November 1, 2020</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>surgical successful rate</measure>
    <time_frame>at 30 days post surgery</time_frame>
    <description>proportion of treated patients free of CSF leak diagnosed by physical examination, biochemical assay, or imaging study within 30 d of the surgical procedure.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>neurosurgical complication</measure>
    <time_frame>2 days post surgery/10 days post surgery/at 30 days post surgery</time_frame>
    <description>Incidence of intracranial infection at 2 days after operation，at discharge，and at 30 days after operation</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">80</enrollment>
  <condition>Cerebrospinal Fluid Leak</condition>
  <arm_group>
    <arm_group_label>DURAFORM</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>DURAFORM was used in repairing cerebral dura mater.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Lyoplant Onlay</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Lyoplant Onlay was used in repairing cerebral dura mater.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Lyoplant Onlay</intervention_name>
    <description>Lyoplant Onlay is a kind of latest artificial Dura Mater</description>
    <arm_group_label>Lyoplant Onlay</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>DURAFORM</intervention_name>
    <description>DURAFORM is a kind of conventional artificial Dura Mater</description>
    <arm_group_label>DURAFORM</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Any patient between the ages of 18 and 75 years scheduled for elective cranial surgery&#xD;
             involving a dural incision.&#xD;
&#xD;
          -  Dural defects and surgical incision was classifed as level 1&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  local or systemic infection.&#xD;
&#xD;
          -  patients with known allergy to Equipment components&#xD;
&#xD;
          -  a history of traumatic head injury&#xD;
&#xD;
          -  a compromised immune system or autoimmune disease&#xD;
&#xD;
          -  patients who should not participate based on the surgeon's opinion&#xD;
&#xD;
          -  patients participating in any other drug or device trial.&#xD;
&#xD;
          -  expected survival time &lt;12 months&#xD;
&#xD;
          -  underwent chemoradiotherapy 3 months before randomization&#xD;
&#xD;
          -  uncontrolled diabetes and malignant tumor&#xD;
&#xD;
          -  women who were pregnant, lactating, or wished to become pregnant during the study;&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>jianmin zhang, M.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Department of neurosurgery</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Jianmin Zhang, M.D.</last_name>
    <phone>+86 0571 87784755</phone>
    <email>zjm135@zju.edu.cn</email>
  </overall_contact>
  <location>
    <facility>
      <name>Jianmin Zhang</name>
      <address>
        <city>Hangzhou</city>
        <state>Zhejiang</state>
        <zip>310000</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Jianmin Zhang, M.D., Ph.D.</last_name>
      <phone>+86 0571 87784755.</phone>
      <email>zjm135@zju.edu.cn</email>
    </contact>
    <investigator>
      <last_name>Jianmin Zhang, M.D.，Ph.D.</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Junming Zhu, M.D.</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>July 2020</verification_date>
  <study_first_submitted>July 16, 2020</study_first_submitted>
  <study_first_submitted_qc>July 26, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 29, 2020</study_first_posted>
  <last_update_submitted>July 26, 2020</last_update_submitted>
  <last_update_submitted_qc>July 26, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 29, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Dura Mater</keyword>
  <keyword>Cerebrospinal Fluid Leak</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Cerebrospinal Fluid Leak</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>The committee will debate whether to share IPD depending on the circumstances. Because some patients are unwilling to make their condition known.</ipd_description>
  </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/NCT04490629
org study id: 2017-126
nct id: NCT04490629
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
This prospective, multi-center, randomized, parallel-controlled clinical trial was designed
      to evaluate the efficacy and safety of Lyoplant Onlay in repairing cerebral dura mater.
      DURAFORM was regarded as the control group. a total of 80 patients were randomized into
      experimental and control group (1:1).Data were collected on complications resulting in CSF
      leaks, surgical site infections, instrument performance parameterized other neurological
      complications within 30 days. Surgeons also provided data on the ease of use of the dural
      sealing techniques, as well as preparation and application times. The above-mentioned date
      were used to evaluate the efficacy and safety of Lyoplant Onlay .
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Participant)
measure: surgical successful rate
time frame: at 30 days post surgery
description: proportion of treated patients free of CSF leak diagnosed by physical examination, biochemical assay, or imaging study within 30 d of the surgical procedure.
measure: neurosurgical complication
time frame: 2 days post surgery/10 days post surgery/at 30 days post surgery
description: Incidence of intracranial infection at 2 days after operation，at discharge，and at 30 days after operation
arm group label: DURAFORM
arm group type: Other
description: DURAFORM was used in repairing cerebral dura mater.
arm group label: Lyoplant Onlay
arm group type: Experimental
description: Lyoplant Onlay was used in repairing cerebral dura mater.
intervention type: Device
intervention name: Lyoplant Onlay
description: Lyoplant Onlay is a kind of latest artificial Dura Mater
arm group label: Lyoplant Onlay
intervention type: Device
intervention name: DURAFORM
description: DURAFORM is a kind of conventional artificial Dura Mater
arm group label: DURAFORM
criteria: 
gender: All
minimum age: 18 Years
maximum age: 75 Years
healthy volunteers: No
last name: jianmin zhang, M.D.
role: Principal Investigator
affiliation: Department of neurosurgery
last name: Jianmin Zhang, M.D.
phone: +86 0571 87784755
email: zjm135@zju.edu.cn
facility: 
status: Recruiting
contact: 
investigator: 
investigator: 
country: China
responsible party type: Sponsor
mesh term: Cerebrospinal Fluid Leak
sharing ipd: No
ipd description: The committee will debate whether to share IPD depending on the circumstances. Because some patients are unwilling to make their condition known.