<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/NCT04466553</url>
  </required_header>
  <id_info>
    <org_study_id>20203097</org_study_id>
    <nct_id>NCT04466553</nct_id>
  </id_info>
  <brief_title>MIS Hematoma Evacuation</brief_title>
  <official_title>MIS Hematoma Evacuation</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Lahey Clinic</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Lahey Clinic</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>
    <is_us_export>Yes</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      The primary objective of this study is to determine the effectiveness of the NICO BrainPath™&#xD;
      hematoma evacuation system for patients between the ages of 18 and 80 years old with an&#xD;
      intracerebral hematoma. Effectiveness will be defined as the ability to achieve either 70%&#xD;
      reduction of intracranial hematoma or to achieve &lt;15 ml residual hematoma volume following&#xD;
      surgery.&#xD;
&#xD;
      Additionally, the study aims to compare the mortality and complication rate of patients who&#xD;
      undergo minimally invasive, navigation guided endoport based evacuation of intracerebral&#xD;
      hematoma with NICO BrainPath™ System as compared to non-operative, supportive standard of&#xD;
      care.&#xD;
&#xD;
      The study is a prospective, non-randomized cohort study. 50 patients will be enrolled in&#xD;
      Group A (NICO BrainPath™ system) and 50 patients will be matched retrospectively of similar&#xD;
      diagnosis, undergoing standard of care from Epic). 50 patients will undergo minimally&#xD;
      invasive, navigation guided endport based evacuation of intracerebral hematoma with NICO&#xD;
      BrainPath™ System. The patient population receiving non-operative supportive care will be&#xD;
      matched to the surgical patients based on age, gender, and location of hemorrhage.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Approximately 100 patients will participate in this study. Patients with significant&#xD;
      intraparenchymal hemorrhage who are admitted under the neurology service in the Neurocritical&#xD;
      Care and Medical ICU will be screened for eligibility.&#xD;
&#xD;
      A repeat CT scan 6 hours after stabilization to show that there has been no increase in size&#xD;
      of the ICH will determine eligibility in the trial. Patients that meet eligibility criteria&#xD;
      after this CT will be taken to the OR within 24-72 hours for a minimally invasive, navigation&#xD;
      guided endoport based evacuation of the clot using the NICO BrainPath™ system.&#xD;
&#xD;
      At baseline, the Glasgow Coma Scale (GCS) and the Modified Rankin Score (mRS) will be&#xD;
      captured, along with baseline demographics. The GCS and mRS will be recorded at 1-, 3, and&#xD;
      6-month post-operatively. A follow-up CT will be captured at 3 months. Mortality and adverse&#xD;
      events will be reviewed at each timepoint.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Withdrawn</overall_status>
  <why_stopped>
    The study did not begin.&#xD;
  </why_stopped>
  <start_date type="Anticipated">October 2021</start_date>
  <completion_date type="Anticipated">August 2022</completion_date>
  <primary_completion_date type="Anticipated">July 2022</primary_completion_date>
  <study_type>Observational [Patient Registry]</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <target_duration>6 Months</target_duration>
  <primary_outcome>
    <measure>Effectiveness of the NICO BrainPath™ hematoma evacuation system</measure>
    <time_frame>immediately after the surgery.</time_frame>
    <description>The primary objective of this study is to determine the effectiveness of the NICO BrainPath™ hematoma evacuation system for patients between the ages of 18 and 80 years old with an intracerebral hematoma. Effectiveness will be defined as the ability to achieve either 70% reduction of intracranial hematoma or to achieve &lt;15 ml residual hematoma volume immediately after the surgery.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Comparison of mortality and complication rate.</measure>
    <time_frame>6 months post-op</time_frame>
    <description>Additionally, the study aims to compare the mortality and complication rate of patients who undergo minimally invasive, navigation guided endoport based evacuation of intracerebral hematoma with NICO BrainPath™ System as compared to non-operative, supportive standard of care until six months post-operative.</description>
  </secondary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">0</enrollment>
  <condition>Intracranial Hematoma</condition>
  <arm_group>
    <arm_group_label>NICO BrainPath™ Patients</arm_group_label>
    <description>50 patients will be enrolled in Group A NICO BrainPath™ system.&#xD;
The NICO BrainPath™ System has been proposed to reduce high morbidity and mortality associated with ICH through minimally invasive clot evacuation. Previous, single-center trials concluded evacuation of ICH using the BrainPath™ system as being safe and effective. Additionally, previous studies concluded that lesser ICH removal was correlated with mortality benefit and that the NICO BrainPath™ system approach was shown to be safe and effective with a high rate of clot evacuation and functional independence. This system warrants further research because of the need to optimize clinical outcome in these patients and to better define the role of hematoma evacuation in the care of these patients.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Standard of Care</arm_group_label>
    <description>50 patients will be matched retrospectively of similar diagnosis, undergoing standard of care (e.g. no surgical intervention). These patients will be matched to the surgical patients based on age, gender, and location of hemorrhage.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>NICO BrainPath™ System</intervention_name>
    <description>Patients who are admitted under the neurology service in the Neurocritical Care and Medical ICU will be screened for participation in the trial by their treating physician. Once blood pressure has been stabilized and the best medical treatment has been determined, the patient will need to undergo a standard of care, repeat CT scan 6 hours after stabilization to show that there has been no increase in size of the ICH. Patients that meet eligibility criteria after this CT will be taken to the OR within 24-72 hours for a minimally invasive, navigation guided endoport based evacuation of the clot using the NICO BrainPath™ system.</description>
    <arm_group_label>NICO BrainPath™ Patients</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Male and females between the ages of 18-80 years old.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. 18 and 80 years of age, inclusive&#xD;
&#xD;
          2. Spontaneous supratentorial, intracerebral hematoma ICH &gt;30 ml measured by the ABC/2&#xD;
             method.&#xD;
&#xD;
          3. Location of Hemorrhage: Lobar, Putaminal and/or Caudate&#xD;
&#xD;
          4. A Glasgow Coma Scale (GCS) of 4 or greater&#xD;
&#xD;
          5. Historical Modified Rankin Score (mRS) of 0 (no symptoms of neurological disability)&#xD;
             or 1 (no significant disability despite symptoms, able to carry out usual duties and&#xD;
             activities).&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Pupils dilated and fixed&#xD;
&#xD;
          2. Rapidly deteriorating patient (at the discretion of the surgeon)&#xD;
&#xD;
          3. Primary Thalamic Bleed&#xD;
&#xD;
          4. Intraventricular Blood (more than 50 % of either ventricle, visual estimate)&#xD;
&#xD;
          5. ICH secondary to aneurysm&#xD;
&#xD;
          6. Arteriovenous malformation (AVM)&#xD;
&#xD;
          7. Tumor&#xD;
&#xD;
          8. Moya-Moya&#xD;
&#xD;
          9. Sinus thrombosis&#xD;
&#xD;
         10. Platelet count &lt;100,000, INR &gt;1.4&#xD;
&#xD;
         11. Known coagulopathy, on anticoagulants that cannot be reversed&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
  </eligibility>
  <overall_official>
    <last_name>Haran Ramachandran, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Lahey Clinic</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Zoher Ghogawala, MD</last_name>
    <role>Study Chair</role>
    <affiliation>Lahey Clinic</affiliation>
  </overall_official>
  <verification_date>December 2021</verification_date>
  <study_first_submitted>July 1, 2020</study_first_submitted>
  <study_first_submitted_qc>July 9, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 10, 2020</study_first_posted>
  <last_update_submitted>December 1, 2021</last_update_submitted>
  <last_update_submitted_qc>December 1, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">December 16, 2021</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</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </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/NCT04466553
org study id: 20203097
nct id: NCT04466553
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: Yes
is us export: Yes
The primary objective of this study is to determine the effectiveness of the NICO BrainPath™
      hematoma evacuation system for patients between the ages of 18 and 80 years old with an
      intracerebral hematoma. Effectiveness will be defined as the ability to achieve either 70%
      reduction of intracranial hematoma or to achieve <15 ml residual hematoma volume following
      surgery.

      Additionally, the study aims to compare the mortality and complication rate of patients who
      undergo minimally invasive, navigation guided endoport based evacuation of intracerebral
      hematoma with NICO BrainPath™ System as compared to non-operative, supportive standard of
      care.

      The study is a prospective, non-randomized cohort study. 50 patients will be enrolled in
      Group A (NICO BrainPath™ system) and 50 patients will be matched retrospectively of similar
      diagnosis, undergoing standard of care from Epic). 50 patients will undergo minimally
      invasive, navigation guided endport based evacuation of intracerebral hematoma with NICO
      BrainPath™ System. The patient population receiving non-operative supportive care will be
      matched to the surgical patients based on age, gender, and location of hemorrhage.
Approximately 100 patients will participate in this study. Patients with significant
      intraparenchymal hemorrhage who are admitted under the neurology service in the Neurocritical
      Care and Medical ICU will be screened for eligibility.

      A repeat CT scan 6 hours after stabilization to show that there has been no increase in size
      of the ICH will determine eligibility in the trial. Patients that meet eligibility criteria
      after this CT will be taken to the OR within 24-72 hours for a minimally invasive, navigation
      guided endoport based evacuation of the clot using the NICO BrainPath™ system.

      At baseline, the Glasgow Coma Scale (GCS) and the Modified Rankin Score (mRS) will be
      captured, along with baseline demographics. The GCS and mRS will be recorded at 1-, 3, and
      6-month post-operatively. A follow-up CT will be captured at 3 months. Mortality and adverse
      events will be reviewed at each timepoint.
observational model: Cohort
time perspective: Prospective
measure: Effectiveness of the NICO BrainPath™ hematoma evacuation system
time frame: immediately after the surgery.
description: The primary objective of this study is to determine the effectiveness of the NICO BrainPath™ hematoma evacuation system for patients between the ages of 18 and 80 years old with an intracerebral hematoma. Effectiveness will be defined as the ability to achieve either 70% reduction of intracranial hematoma or to achieve <15 ml residual hematoma volume immediately after the surgery.
measure: Comparison of mortality and complication rate.
time frame: 6 months post-op
description: Additionally, the study aims to compare the mortality and complication rate of patients who undergo minimally invasive, navigation guided endoport based evacuation of intracerebral hematoma with NICO BrainPath™ System as compared to non-operative, supportive standard of care until six months post-operative.
arm group label: NICO BrainPath™ Patients
description: 50 patients will be enrolled in Group A NICO BrainPath™ system.
The NICO BrainPath™ System has been proposed to reduce high morbidity and mortality associated with ICH through minimally invasive clot evacuation. Previous, single-center trials concluded evacuation of ICH using the BrainPath™ system as being safe and effective. Additionally, previous studies concluded that lesser ICH removal was correlated with mortality benefit and that the NICO BrainPath™ system approach was shown to be safe and effective with a high rate of clot evacuation and functional independence. This system warrants further research because of the need to optimize clinical outcome in these patients and to better define the role of hematoma evacuation in the care of these patients.
arm group label: Standard of Care
description: 50 patients will be matched retrospectively of similar diagnosis, undergoing standard of care (e.g. no surgical intervention). These patients will be matched to the surgical patients based on age, gender, and location of hemorrhage.
intervention type: Device
intervention name: NICO BrainPath™ System
description: Patients who are admitted under the neurology service in the Neurocritical Care and Medical ICU will be screened for participation in the trial by their treating physician. Once blood pressure has been stabilized and the best medical treatment has been determined, the patient will need to undergo a standard of care, repeat CT scan 6 hours after stabilization to show that there has been no increase in size of the ICH. Patients that meet eligibility criteria after this CT will be taken to the OR within 24-72 hours for a minimally invasive, navigation guided endoport based evacuation of the clot using the NICO BrainPath™ system.
arm group label: NICO BrainPath™ Patients
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 80 Years
last name: Haran Ramachandran, MD
role: Principal Investigator
affiliation: Lahey Clinic
last name: Zoher Ghogawala, MD
role: Study Chair
affiliation: Lahey Clinic
responsible party type: Sponsor
mesh term: Hematoma
sharing ipd: Undecided