<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/NCT04494295</url>
  </required_header>
  <id_info>
    <org_study_id>C-MIRROR-001</org_study_id>
    <nct_id>NCT04494295</nct_id>
  </id_info>
  <brief_title>The MIRROR Registry: Minimally Invasive IntRaceRebral HemORrhage Evacuation</brief_title>
  <acronym>MIRROR</acronym>
  <official_title>The MIRROR Registry: Minimally Invasive IntRaceRebral HemORrhage Evacuation</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Integra LifeSciences Corporation</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Icahn School of Medicine at Mount Sinai</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Oculus Imaging LLC</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Integra LifeSciences Corporation</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>
  </oversight_info>
  <brief_summary>
    <textblock>
      This registry will study the use of the Aurora® Surgiscope to provide surgical access and&#xD;
      visualization in minimally invasive removal of hematoma in the brain. Many methods of&#xD;
      hematoma removal are available and will be based on surgeon preference. The impact of patient&#xD;
      selection and time to surgery from last known well time will be explored.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">October 23, 2020</start_date>
  <completion_date type="Anticipated">October 15, 2029</completion_date>
  <primary_completion_date type="Anticipated">October 15, 2028</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>Rate of Surgical Success</measure>
    <time_frame>During surgical procedure to evacuate supratentorial intracerebral hemorrhage</time_frame>
    <description>Rate of surgical success defined as reduction to &lt; 15 cc total volume of the supratentorial intracerebral hemorrhage on immediate Post-op CT Scan</description>
  </primary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Anticipated">500</enrollment>
  <condition>Supratentorial Hemorrhage</condition>
  <arm_group>
    <arm_group_label>AURORA</arm_group_label>
    <description>Aurora® Surgiscope used for MIS evacuation of supratentorial hematoma</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Aurora Surgiscope System</intervention_name>
    <description>MIS evacuation of hematoma using the Aurora Surgiscope System</description>
    <arm_group_label>AURORA</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        general population with an acute, spontaneous, primary, supratentorial ICH&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Subject Age is &gt; 18&#xD;
&#xD;
          -  Subject with a Head CT that demonstrates an acute, spontaneous, primary,&#xD;
             supratentorial ICH of volume &gt; 20 mL, assessed via standard of care techniques&#xD;
&#xD;
          -  Subject Surgery can be initiated within 24 hours of the last known well time or, in&#xD;
             patients with wake-up onset, within 24 hours of the time the patient awoke with&#xD;
             symptoms.&#xD;
&#xD;
          -  Subject has a NIHSS score &gt; 5&#xD;
&#xD;
          -  Subject has a baseline Modified Rankin Scale (mRS) Score ≤ 2&#xD;
&#xD;
          -  Subject with a CT Angiography demonstrating no vascular malformation&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Subject has an underlying vascular lesion defined as causative source of ICH&#xD;
&#xD;
          -  Subject has a profound neurological deficit defined as fixed/dilated pupils or&#xD;
             bilateral extensor motor posturing&#xD;
&#xD;
          -  Subject has an Infratentorial or brainstem ICH&#xD;
&#xD;
          -  Subject has a known life expectancy &lt; 6 months&#xD;
&#xD;
          -  Subject has an uncorrectable coagulopathy&#xD;
&#xD;
          -  Subject has a mechanical heart valve&#xD;
&#xD;
          -  Subject is pregnant&#xD;
&#xD;
          -  Subject participates in another concurrent interventional clinical trial&#xD;
&#xD;
          -  Subject who is unable to meet study follow-up requirements&#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>Jason Marzuola, MSN</last_name>
    <role>Study Director</role>
    <affiliation>Integra LifeSciences Corporation</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Christopher Kellner, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Icahn School of Medicine at Mount Sinai</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Crystal George</last_name>
    <phone>4699684132</phone>
    <email>crystal.george@integralife.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>University of South Florida</name>
      <address>
        <city>Tampa</city>
        <state>Florida</state>
        <zip>33606</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Kassandra Jones</last_name>
      <email>kassandraj@usf.edu</email>
    </contact>
    <investigator>
      <last_name>Kunal Vakharia, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Rush University Medical Center</name>
      <address>
        <city>Chicago</city>
        <state>Illinois</state>
        <zip>60612</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Bart Jacher</last_name>
    </contact>
    <investigator>
      <last_name>R. Webster Crowley, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Spectrum Health</name>
      <address>
        <city>Grand Rapids</city>
        <state>Michigan</state>
        <zip>49503</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Beenish Sultan</last_name>
      <email>beenish.ismail@spectrumhealth.org</email>
    </contact>
    <investigator>
      <last_name>Justin Singer, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>University of Missouri</name>
      <address>
        <city>Columbia</city>
        <state>Missouri</state>
        <zip>65201</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Jennifer Randolph</last_name>
      <email>randolphjl@health.missouri.edu</email>
    </contact>
    <investigator>
      <last_name>Michael Chicoine, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Washington University in St. Louis</name>
      <address>
        <city>Saint Louis</city>
        <state>Missouri</state>
        <zip>63110</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Brigette Vaughn</last_name>
    </contact>
    <investigator>
      <last_name>Joshua Osbun, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>University at Buffalo</name>
      <address>
        <city>Buffalo</city>
        <state>New York</state>
        <zip>14260</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Jennifer Gay</last_name>
    </contact>
    <investigator>
      <last_name>Adnan Siddiqui, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Icahn School of Medicine at Mount Sinai</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10029</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Nicole Smeck</last_name>
    </contact>
    <investigator>
      <last_name>Tomoyoshi Shigematsu, MD, PhD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Cleveland Clinic</name>
      <address>
        <city>Cleveland</city>
        <state>Ohio</state>
        <zip>44195</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Joyce Barmen</last_name>
      <email>barmenj2@ccf.org</email>
    </contact>
    <investigator>
      <last_name>Mark Bain, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>University of Oklahoma</name>
      <address>
        <city>Oklahoma City</city>
        <state>Oklahoma</state>
        <zip>73104</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Michael Omini</last_name>
      <email>michael-omini@ouhsc.edu</email>
    </contact>
    <investigator>
      <last_name>Andrew Bauer, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>University of Pennsylvania</name>
      <address>
        <city>Philadelphia</city>
        <state>Pennsylvania</state>
        <zip>19104</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Terminated</status>
  </location>
  <location>
    <facility>
      <name>Prisma Health - Upstate</name>
      <address>
        <city>Greenville</city>
        <state>South Carolina</state>
        <zip>29601</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Rosie Gaddy</last_name>
    </contact>
    <investigator>
      <last_name>Raymond Turner, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>University of Washington - Harborview</name>
      <address>
        <city>Seattle</city>
        <state>Washington</state>
        <zip>98104</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Jade Keen</last_name>
    </contact>
    <investigator>
      <last_name>Michael Levitt, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>June 2023</verification_date>
  <study_first_submitted>July 28, 2020</study_first_submitted>
  <study_first_submitted_qc>July 28, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 31, 2020</study_first_posted>
  <last_update_submitted>June 27, 2023</last_update_submitted>
  <last_update_submitted_qc>June 27, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">June 28, 2023</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>Cerebral Hemorrhage</mesh_term>
    <mesh_term>Hemorrhage</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/NCT04494295
org study id: C-MIRROR-001
nct id: NCT04494295
lead sponsor: 
collaborator: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: Yes
This registry will study the use of the Aurora® Surgiscope to provide surgical access and
      visualization in minimally invasive removal of hematoma in the brain. Many methods of
      hematoma removal are available and will be based on surgeon preference. The impact of patient
      selection and time to surgery from last known well time will be explored.
observational model: Case-Only
time perspective: Prospective
measure: Rate of Surgical Success
time frame: During surgical procedure to evacuate supratentorial intracerebral hemorrhage
description: Rate of surgical success defined as reduction to < 15 cc total volume of the supratentorial intracerebral hemorrhage on immediate Post-op CT Scan
arm group label: AURORA
description: Aurora® Surgiscope used for MIS evacuation of supratentorial hematoma
intervention type: Device
intervention name: Aurora Surgiscope System
description: MIS evacuation of hematoma using the Aurora Surgiscope System
arm group label: AURORA
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Jason Marzuola, MSN
role: Study Director
affiliation: Integra LifeSciences Corporation
last name: Christopher Kellner, MD
role: Principal Investigator
affiliation: Icahn School of Medicine at Mount Sinai
last name: Crystal George
phone: 4699684132
email: crystal.george@integralife.com
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Not yet recruiting
contact: 
investigator: 
facility: 
status: Not yet recruiting
contact: 
investigator: 
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Terminated
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Recruiting
contact: 
investigator: 
country: United States
responsible party type: Sponsor
mesh term: Cerebral Hemorrhage
mesh term: Hemorrhage