<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/NCT03276286</url>
  </required_header>
  <id_info>
    <org_study_id>NAT109</org_study_id>
    <nct_id>NCT03276286</nct_id>
  </id_info>
  <brief_title>Nativis Voyager for Newly Diagnosed GBM</brief_title>
  <acronym>NAT109</acronym>
  <official_title>A Feasibility Study of the Nativis Voyager® System in Patients With Newly Diagnosed Glioblastoma Multiforme (GBM)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Nativis, Inc.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Nativis, Inc.</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_unapproved_device>Yes</is_unapproved_device>
    <is_us_export>Yes</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      This feasibility study will assess the effects of the Nativis Voyager therapy in patients&#xD;
      newly diagnosed with GBM. The study will enroll and treat up to 32 subjects and will be&#xD;
      combined with standard of care radiotherapy and temozolomide.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">November 10, 2017</start_date>
  <completion_date type="Actual">May 31, 2022</completion_date>
  <primary_completion_date type="Actual">May 31, 2022</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <intervention_model_description>Nativis Voyager combined with standard radiotherapy and temozolomide</intervention_model_description>
    <primary_purpose>Device Feasibility</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Treatment-related Adverse Events (Safety)</measure>
    <time_frame>Through study completion, average of 1 year</time_frame>
    <description>Safety as measured by number of investigational treatment-related adverse events as assessed by CTCAE v4.0.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Clinical Utility PFS</measure>
    <time_frame>6 months</time_frame>
    <description>Progression Free Survival</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Clinical Utility OS</measure>
    <time_frame>Through patient completion, expected average 8 months</time_frame>
    <description>Overall Survival</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">37</enrollment>
  <condition>Glioblastoma Multiforme</condition>
  <arm_group>
    <arm_group_label>Nativis Voyager</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Nativis Voyager combined with SOC Radiotherapy and temozolomide</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Nativis Voyager</intervention_name>
    <description>Nativis Voyager treatment combined with standard of care radiotherapy and temozolomide</description>
    <arm_group_label>Nativis Voyager</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  There is pathological evidence of GBM using World Health Organization (WHO)&#xD;
             classification.&#xD;
&#xD;
          -  Subject received maximal debulking surgery. Patients may enroll in the study if&#xD;
             received Gliadel wafers before entering the trial. Any additional treatments received&#xD;
             prior to enrollment will be considered an exclusion.&#xD;
&#xD;
          -  Subject must have at least one measurable lesion per RANO.&#xD;
&#xD;
          -  Subject is at least 18 years of age.&#xD;
&#xD;
          -  Subject has a Karnofsky Performance Scale (KPS) ≥ 60.&#xD;
&#xD;
          -  Subject has life expectancy &gt; 3 months.&#xD;
&#xD;
          -  Subject has adequate organ and marrow function; see note 1.&#xD;
&#xD;
          -  Subject able to start treatment at least 28 days from tumor resection surgery.&#xD;
&#xD;
          -  Subject has provided signed informed consent.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Subject has progressive disease per RANO. If pseudoprogression is suspected,&#xD;
             additional imaging studies must be performed to rule out true progression.&#xD;
&#xD;
          -  Evidence of increased intracranial pressure (midline shift &gt; 5mm, clinically&#xD;
             significant papilledema, vomiting and nausea or reduced level of consciousness)&#xD;
&#xD;
          -  Subject is currently being treated with Optune.&#xD;
&#xD;
          -  Subject is currently being treated with other investigational agents.&#xD;
&#xD;
          -  Subject has not sufficiently recovered from prior surgery in the opinion of the&#xD;
             investigator.&#xD;
&#xD;
          -  Subject has significant co-morbidities at baseline which would prevent radiotherapy&#xD;
             and/or temozolomide treatment.&#xD;
&#xD;
          -  Subject has history of hypersensitivity reaction to temozolomide or a history of&#xD;
             hypersensitivity to dacarbazine (DTIC).&#xD;
&#xD;
          -  Subject has a clinically significant electrolyte abnormality.&#xD;
&#xD;
          -  Subject has an active implantable (e.g., neurostimulator, pacemaker) or other&#xD;
             electromagnetic device that is incompatible with MRI. Subjects with programmable shunt&#xD;
             are excluded from the study.&#xD;
&#xD;
          -  Subject has a metal implant, including a stent, in the head or neck that is&#xD;
             incompatible with MRI.&#xD;
&#xD;
          -  Subject is known to be HIV positive.&#xD;
&#xD;
          -  Subject is pregnant, nursing or intends to become pregnant during the study period.&#xD;
&#xD;
          -  Subject is participating in other potentially confounding investigational research.&#xD;
&#xD;
          -  Subject has any condition that at the discretion of the investigator would preclude&#xD;
             participation in the study.&#xD;
&#xD;
          -  Subject is unable or unwilling to comply with the protocol-required follow-up&#xD;
             schedule.&#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>Donna Morgan Murray, PhD</last_name>
    <role>Study Chair</role>
    <affiliation>Nativis, Inc.</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Center for Neurosciences</name>
      <address>
        <city>Tucson</city>
        <state>Arizona</state>
        <zip>85718</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>California Cancer Care Associates</name>
      <address>
        <city>Encinitas</city>
        <state>California</state>
        <zip>92024</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>John Wayne Cancer Institute @ Providence St Johns Health Center</name>
      <address>
        <city>Santa Monica</city>
        <state>California</state>
        <zip>90404</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Associated Neurologists of Southern CT, PC</name>
      <address>
        <city>Fairfield</city>
        <state>Connecticut</state>
        <zip>06824</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Boca Raton Regional Hospital</name>
      <address>
        <city>Boca Raton</city>
        <state>Florida</state>
        <zip>33486</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Cancer Care Collaborative</name>
      <address>
        <city>Austin</city>
        <state>Texas</state>
        <zip>78705</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Baylor Scott and White Health</name>
      <address>
        <city>Temple</city>
        <state>Texas</state>
        <zip>98101</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>January 2023</verification_date>
  <study_first_submitted>September 5, 2017</study_first_submitted>
  <study_first_submitted_qc>September 6, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 8, 2017</study_first_posted>
  <last_update_submitted>January 31, 2023</last_update_submitted>
  <last_update_submitted_qc>January 31, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">February 2, 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>Glioblastoma</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</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/NCT03276286
org study id: NAT109
nct id: NCT03276286
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: Yes
is unapproved device: Yes
is us export: Yes
This feasibility study will assess the effects of the Nativis Voyager therapy in patients
      newly diagnosed with GBM. The study will enroll and treat up to 32 subjects and will be
      combined with standard of care radiotherapy and temozolomide.
allocation: N/A
intervention model: Single Group Assignment
intervention model description: Nativis Voyager combined with standard radiotherapy and temozolomide
primary purpose: Device Feasibility
masking: None (Open Label)
measure: Treatment-related Adverse Events (Safety)
time frame: Through study completion, average of 1 year
description: Safety as measured by number of investigational treatment-related adverse events as assessed by CTCAE v4.0.
measure: Clinical Utility PFS
time frame: 6 months
description: Progression Free Survival
measure: Clinical Utility OS
time frame: Through patient completion, expected average 8 months
description: Overall Survival
arm group label: Nativis Voyager
arm group type: Experimental
description: Nativis Voyager combined with SOC Radiotherapy and temozolomide
intervention type: Device
intervention name: Nativis Voyager
description: Nativis Voyager treatment combined with standard of care radiotherapy and temozolomide
arm group label: Nativis Voyager
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Donna Morgan Murray, PhD
role: Study Chair
affiliation: Nativis, Inc.
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
country: United States
responsible party type: Sponsor
mesh term: Glioblastoma
sharing ipd: No