<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/NCT04402632</url>
  </required_header>
  <id_info>
    <org_study_id>MDT19027ONYX</org_study_id>
    <nct_id>NCT04402632</nct_id>
  </id_info>
  <brief_title>Embolization of the Middle Meningeal Artery With ONYX™ Liquid Embolic System for Subacute and Chronic Subdural Hematoma</brief_title>
  <acronym>EMBOLISE</acronym>
  <official_title>A Study of the Embolization of the Middle Meningeal Artery With ONYX™ Liquid Embolic System In the Treatment of Subacute and Chronic Subdural HEmatoma (EMBOLISE)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Medtronic Neurovascular Clinical Affairs</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Medtronic Neurovascular Clinical Affairs</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>Yes</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to evaluate the safety and efficacy of embolization of the&#xD;
      middle meningeal artery (MMA) using the Onyx™ Liquid Embolic System (LES) for treatment of&#xD;
      symptomatic subacute or chronic subdural hematoma (SDH)&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">October 27, 2020</start_date>
  <completion_date type="Anticipated">August 2024</completion_date>
  <primary_completion_date type="Anticipated">May 2024</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>Sequential Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Effectiveness: Incidence of hematoma recurrence/progression requiring re-intervention</measure>
    <time_frame>90 days post-procedure</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Non-inferiority assessment of Onyx™ LES embolization treatment compared to standard of care based on change in Modified Rankin Scale Score</measure>
    <time_frame>90 days post-procedure</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Effectiveness: Incidence of hospital readmissions</measure>
    <time_frame>90 days post-procedure</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Effectiveness: Change in hematoma volume based on CT/MRI imaging</measure>
    <time_frame>90 days post-procedure</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Effectiveness: Change in hematoma thickness per CT/MRI imaging</measure>
    <time_frame>90 days post-procedure</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Effectiveness: Change in midline shift based on CT/MRI imaging</measure>
    <time_frame>90 days post-procedure</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Safety: Incidence of device-related serious adverse events</measure>
    <time_frame>30 days post-procedure</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Safety: Incidence of procedure-related serious adverse events</measure>
    <time_frame>30 days post-procedure</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Safety: Incidence of neurological death</measure>
    <time_frame>90 days and 180 days post-procedure</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Safety: Incidence of device-related adverse events</measure>
    <time_frame>90 days and 180 days post-procedure</time_frame>
  </secondary_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Anticipated">600</enrollment>
  <condition>Subdural Hematoma</condition>
  <arm_group>
    <arm_group_label>Surgery Cohort: Control Arm</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Control</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Surgery Cohort: Treatment Arm</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Treatment</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Observational Cohort: Control Arm</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Control</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Observational Cohort: Treatment Arm</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Treatment</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Surgical Management</intervention_name>
    <description>SDH Evacuation (Control)</description>
    <arm_group_label>Surgery Cohort: Control Arm</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Surgical Management + Treatment</intervention_name>
    <description>SDH Evacuation + Onyx™ LES Embolization</description>
    <arm_group_label>Surgery Cohort: Treatment Arm</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>No Treatment</intervention_name>
    <description>Observation Only (Control)</description>
    <arm_group_label>Observational Cohort: Control Arm</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Treatment</intervention_name>
    <description>Onyx™ LES Embolization</description>
    <arm_group_label>Observational Cohort: Treatment Arm</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Pre-morbid Modified Rankin Score ≤3&#xD;
&#xD;
          -  Confirmed diagnosis of subacute or chronic subdural hematoma&#xD;
&#xD;
          -  Completed informed consent&#xD;
&#xD;
          -  Meets criteria for Surgery or Observation Cohort&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Life expectancy &lt;1 year&#xD;
&#xD;
          -  Unable to complete follow-up&#xD;
&#xD;
          -  Pregnant, lactating, or has a positive pregnancy test at time of admission&#xD;
&#xD;
          -  Diagnosed with acute SDH&#xD;
&#xD;
          -  Potentially dangerous anatomic variations leading to increased procedural risk or&#xD;
             unsafe access for MMA embolization&#xD;
&#xD;
          -  Pre-randomized Markwalder Grading Scale score ≥ 3&#xD;
&#xD;
          -  Unmanaged, uncontrolled bleeding disorders/blood diathesis&#xD;
&#xD;
          -  Presumed septic embolus, or suspicion of microbial superinfection&#xD;
&#xD;
          -  Known active COVID-19 infection&#xD;
&#xD;
          -  CT or MRI evidence of intra-cranial tumor or mass lesion Contraindication to&#xD;
             angiography&#xD;
&#xD;
          -  Participation in another clinical trial&#xD;
&#xD;
          -  Contraindicated for the use of Onyx™ LES&#xD;
&#xD;
          -  Cannot be taken off corticosteroids (intended to treat subacute or chronic SDH) for at&#xD;
             least 90 days post-randomization&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>90 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Jared Knopman, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>New York-Presbyterian Hospital/Weill Cornell Medical Center</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Jason Davies, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Buffalo General Medical Center</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Medtronic Neurovascular Clinical Affairs</last_name>
    <phone>1(949) 837-3700</phone>
    <email>rs.embolisestudy@medtronic.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>University of Alabama at Birmingham (UAB) Hospital</name>
      <address>
        <city>Birmingham</city>
        <state>Alabama</state>
        <zip>35233-1932</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Jesse Jones, MD</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Carondelet St. Joseph's Hospital</name>
      <address>
        <city>Tucson</city>
        <state>Arizona</state>
        <zip>85710</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Alexander Coon, MD</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>University of California Irvine Medical Center</name>
      <address>
        <city>Irvine</city>
        <state>California</state>
        <zip>92868</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Shuichi Suzuki, MD</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>USC - Keck School of Medicine</name>
      <address>
        <city>Los Angeles</city>
        <state>California</state>
        <zip>90033</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>William Mack, MD</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Huntington Memorial Hospital</name>
      <address>
        <city>Pasadena</city>
        <state>California</state>
        <zip>91105</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Ian Ross, MD</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>UCSD Medical Center</name>
      <address>
        <city>San Diego</city>
        <state>California</state>
        <zip>92037</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Jeffrey Pannell, MD</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Providence Little Company of Mary Medical Center</name>
      <address>
        <city>Torrance</city>
        <state>California</state>
        <zip>90503-4607</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Jason Tarpley, MD</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>University of Colorado Denver School of Medicine</name>
      <address>
        <city>Aurora</city>
        <state>Colorado</state>
        <zip>80045</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Christopher Roark, MD</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>UF Health Heart and Vascular Hospital</name>
      <address>
        <city>Gainesville</city>
        <state>Florida</state>
        <zip>32608</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Adam Polifka, MD</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Baptist Medical Center Jacksonville</name>
      <address>
        <city>Jacksonville</city>
        <state>Florida</state>
        <zip>322047</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Ricardo Hanel, MD</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Jackson Memorial Hospital</name>
      <address>
        <city>Miami</city>
        <state>Florida</state>
        <zip>33136</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Robert Starke, MD</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Orlando Regional Medical Center Orlando Health</name>
      <address>
        <city>Orlando</city>
        <state>Florida</state>
        <zip>32806</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Marshall Cress, MD</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Tampa General Hospital</name>
      <address>
        <city>Tampa</city>
        <state>Florida</state>
        <zip>33606</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Maxim Mokin, MD</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Saint Mary's Medical Center</name>
      <address>
        <city>West Palm Beach</city>
        <state>Florida</state>
        <zip>33407</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Ali Malek, MD</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Grady Memorial Hospital</name>
      <address>
        <city>Atlanta</city>
        <state>Georgia</state>
        <zip>30303</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Jonathan Grossberg, MD</last_name>
    </contact>
  </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>Richard Webster Crowley, MD</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Advocate Lutheran General Hospital</name>
      <address>
        <city>Park Ridge</city>
        <state>Illinois</state>
        <zip>60068</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Joshua Billingsley, MD</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Ascension Saint Vincent Hospital</name>
      <address>
        <city>Indianapolis</city>
        <state>Indiana</state>
        <zip>46260</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Daniel Sahlein, MD</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>University of Iowa Hospitals and Clinics</name>
      <address>
        <city>Iowa City</city>
        <state>Iowa</state>
        <zip>52242</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Kathleen Dlouhy, MD</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>University of Kentucky Albert B Chandler Hospital</name>
      <address>
        <city>Lexington</city>
        <state>Kentucky</state>
        <zip>40506</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Justin Fraser, MD</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Brigham and Women's Hospital</name>
      <address>
        <city>Boston</city>
        <state>Massachusetts</state>
        <zip>02115</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Mohammad Aziz-Sultan, MD</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Lahey Hospital &amp; Medical Center</name>
      <address>
        <city>Burlington</city>
        <state>Massachusetts</state>
        <zip>01805-0001</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Neil Patel, MD</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>McLaren Flint Hospital</name>
      <address>
        <city>Flint</city>
        <state>Michigan</state>
        <zip>48532</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Aniel Majjhoo, MD</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Spectrum Health Hospital</name>
      <address>
        <city>Grand Rapids</city>
        <state>Michigan</state>
        <zip>49503</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Justin Singer, MD</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Barnes-Jewish Hospital</name>
      <address>
        <city>Saint Louis</city>
        <state>Missouri</state>
        <zip>63110</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Joshua Osbun, MD</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Albany Medical Center</name>
      <address>
        <city>Albany</city>
        <state>New York</state>
        <zip>12208</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Alexandra Paul, MD</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Buffalo General Medical Center</name>
      <address>
        <city>Buffalo</city>
        <state>New York</state>
        <zip>14203</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Jason Davies, MD</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>North Shore University Hospital</name>
      <address>
        <city>Manhasset</city>
        <state>New York</state>
        <zip>11030</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Thomas Link, MD</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>The Mount Sinai Hospital</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10029</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Active, not recruiting</status>
  </location>
  <location>
    <facility>
      <name>New York-Presbyterian Hospital/Weill Cornell Medical Center</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10065</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Jared Knopman, MD</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Westchester Medical Center</name>
      <address>
        <city>Valhalla</city>
        <state>New York</state>
        <zip>10595</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Justin Santarelli, MD</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Atrium Health's Carolinas Medical Center</name>
      <address>
        <city>Charlotte</city>
        <state>North Carolina</state>
        <zip>28204</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Joe Bernard, MD</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Cleveland Clinic</name>
      <address>
        <city>Cleveland</city>
        <state>Ohio</state>
        <zip>44195-0001</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Mark Bain, MD</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>The Ohio State University/Wexner Medical Center</name>
      <address>
        <city>Columbus</city>
        <state>Ohio</state>
        <zip>43210</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Patrick Youssef, MD</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>ProMedica Toledo Hospital</name>
      <address>
        <city>Toledo</city>
        <state>Ohio</state>
        <zip>43606</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Mouhammad Jumaa, MD</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Oklahoma University Medical Center</name>
      <address>
        <city>Oklahoma City</city>
        <state>Oklahoma</state>
        <zip>73104</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Hakeem Shakir, MD</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Oregon Health &amp; Science University Hospital</name>
      <address>
        <city>Portland</city>
        <state>Oregon</state>
        <zip>97239-3011</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Jesse Liu, MD</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Geisinger Medical Center</name>
      <address>
        <city>Danville</city>
        <state>Pennsylvania</state>
        <zip>17822</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Clemens Schirmer, MD</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>University of Pittsburgh Medical Center UPMC Presbyterian</name>
      <address>
        <city>Pittsburgh</city>
        <state>Pennsylvania</state>
        <zip>15213-2536</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Bradley Gross, MD</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Prisma Health</name>
      <address>
        <city>Greenville</city>
        <state>South Carolina</state>
        <zip>29605</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Mohammad Chaudry, MD</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Valley Baptist Medical Center</name>
      <address>
        <city>Harlingen</city>
        <state>Texas</state>
        <zip>78550</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Ameer Hassan, MD</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Memorial Hermann-Texas Medical Center</name>
      <address>
        <city>Houston</city>
        <state>Texas</state>
        <zip>77030</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Peng Chen, MD</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Baylor Scott &amp; White Medical Center - Temple</name>
      <address>
        <city>Temple</city>
        <state>Texas</state>
        <zip>76508-0001</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Walter Lesley, MD</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>University of Utah Hospital</name>
      <address>
        <city>Salt Lake City</city>
        <state>Utah</state>
        <zip>84132</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Ramesh Grandhi, MD</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Harborview Medical Center</name>
      <address>
        <city>Seattle</city>
        <state>Washington</state>
        <zip>98104-2420</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Michael Levitt, MD</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Aurora Saint Luke's Medical Center</name>
      <address>
        <city>Milwaukee</city>
        <state>Wisconsin</state>
        <zip>53215</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Thomas Wolfe, MD</last_name>
    </contact>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>July 2023</verification_date>
  <study_first_submitted>May 18, 2020</study_first_submitted>
  <study_first_submitted_qc>May 20, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">May 27, 2020</study_first_posted>
  <last_update_submitted>July 20, 2023</last_update_submitted>
  <last_update_submitted_qc>July 20, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">July 21, 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>Hematoma, Subdural</mesh_term>
    <mesh_term>Hematoma, Subdural, Chronic</mesh_term>
    <mesh_term>Hematoma</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>No individual participant data will be available</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/NCT04402632
org study id: MDT19027ONYX
nct id: NCT04402632
lead sponsor: 
is fda regulated drug: No
is fda regulated device: Yes
The purpose of this study is to evaluate the safety and efficacy of embolization of the
      middle meningeal artery (MMA) using the Onyx™ Liquid Embolic System (LES) for treatment of
      symptomatic subacute or chronic subdural hematoma (SDH)
allocation: Randomized
intervention model: Sequential Assignment
primary purpose: Treatment
masking: Single (Outcomes Assessor)
measure: Effectiveness: Incidence of hematoma recurrence/progression requiring re-intervention
time frame: 90 days post-procedure
measure: Non-inferiority assessment of Onyx™ LES embolization treatment compared to standard of care based on change in Modified Rankin Scale Score
time frame: 90 days post-procedure
measure: Effectiveness: Incidence of hospital readmissions
time frame: 90 days post-procedure
measure: Effectiveness: Change in hematoma volume based on CT/MRI imaging
time frame: 90 days post-procedure
measure: Effectiveness: Change in hematoma thickness per CT/MRI imaging
time frame: 90 days post-procedure
measure: Effectiveness: Change in midline shift based on CT/MRI imaging
time frame: 90 days post-procedure
measure: Safety: Incidence of device-related serious adverse events
time frame: 30 days post-procedure
measure: Safety: Incidence of procedure-related serious adverse events
time frame: 30 days post-procedure
measure: Safety: Incidence of neurological death
time frame: 90 days and 180 days post-procedure
measure: Safety: Incidence of device-related adverse events
time frame: 90 days and 180 days post-procedure
arm group label: Surgery Cohort: Control Arm
arm group type: Active Comparator
description: Control
arm group label: Surgery Cohort: Treatment Arm
arm group type: Experimental
description: Treatment
arm group label: Observational Cohort: Control Arm
arm group type: Active Comparator
description: Control
arm group label: Observational Cohort: Treatment Arm
arm group type: Experimental
description: Treatment
intervention type: Procedure
intervention name: Surgical Management
description: SDH Evacuation (Control)
arm group label: Surgery Cohort: Control Arm
intervention type: Device
intervention name: Surgical Management + Treatment
description: SDH Evacuation + Onyx™ LES Embolization
arm group label: Surgery Cohort: Treatment Arm
intervention type: Other
intervention name: No Treatment
description: Observation Only (Control)
arm group label: Observational Cohort: Control Arm
intervention type: Device
intervention name: Treatment
description: Onyx™ LES Embolization
arm group label: Observational Cohort: Treatment Arm
criteria: 
gender: All
minimum age: 18 Years
maximum age: 90 Years
healthy volunteers: No
last name: Jared Knopman, MD
role: Principal Investigator
affiliation: New York-Presbyterian Hospital/Weill Cornell Medical Center
last name: Jason Davies, MD
role: Principal Investigator
affiliation: Buffalo General Medical Center
last name: Medtronic Neurovascular Clinical Affairs
phone: 1(949) 837-3700
email: rs.embolisestudy@medtronic.com
facility: 
status: Recruiting
contact: 
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status: Recruiting
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status: Recruiting
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status: Recruiting
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status: Recruiting
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status: Recruiting
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status: Recruiting
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status: Recruiting
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status: Recruiting
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status: Recruiting
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status: Recruiting
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status: Recruiting
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status: Active, not recruiting
facility: 
status: Recruiting
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status: Recruiting
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status: Recruiting
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status: Recruiting
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status: Recruiting
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status: Recruiting
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status: Recruiting
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status: Recruiting
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status: Recruiting
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status: Recruiting
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status: Recruiting
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status: Recruiting
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status: Recruiting
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status: Recruiting
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status: Recruiting
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status: Recruiting
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status: Recruiting
contact: 
country: United States
responsible party type: Sponsor
mesh term: Hematoma, Subdural
mesh term: Hematoma, Subdural, Chronic
mesh term: Hematoma
sharing ipd: No
ipd description: No individual participant data will be available