xml: <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/NCT06008613</url>
    </required_header>
    <id_info>
      <org_study_id>23-753</org_study_id>
      <secondary_id>5R44HL139290-03</secondary_id>
      <nct_id>NCT06008613</nct_id>
    </id_info>
    <brief_title>3D Holographic Guidance, Navigation, and Control for Endovascular Aortic Repair</brief_title>
    <acronym>3D-GN&amp;C</acronym>
    <official_title>3D Holographic Guidance, Navigation, and Control (3D GN&amp;C) for Endovascular Aortic Repair (EVAR)</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>The Cleveland Clinic</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>National Heart, Lung, and Blood Institute (NHLBI)</agency>
        <agency_class>NIH</agency_class>
      </collaborator>
    </sponsors>
    <source>The Cleveland 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>
    </oversight_info>
    <brief_summary>
      <textblock>
        This is an Early Feasibility Study to evaluate the usability, safety and functionality of 3D&#xD;
        holographic guidance, navigation, and control (3D-GNC) as an adjunct to and confirmed by&#xD;
        fluoroscopic imaging to be used with Cook Zenith Flex AAA Endovascular Graft.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        The goal of this clinical study is to evaluate the feasibility of using electromagnetic (EM)&#xD;
        guidance and tracking to precisely place a Cook Zenith Flex AAA bifurcated stent graft during&#xD;
        EVAR. EM guidance and tracking is enabled using a system consisting of the following: 1)&#xD;
        experimental 3D guidance, navigation, and control (3D-GNC) software developed by Centerline&#xD;
        Biomedical, Inc., integrated with the company's FDA-cleared Intra-Operative Positioning&#xD;
        System (IOPS), 2) FDA-cleared compatible sensorized guidewires added to the Cook Zenith Flex&#xD;
        delivery system and 3) 3D visualization on the IOPS mobile cart monitor and 3D holographic&#xD;
        visualization overlaid on the patient during the procedure using a head mounted display&#xD;
        (HMD), the Microsoft HoloLens 2. Planning and execution of each case will be major steps in&#xD;
        demonstrating feasibility of the technology beyond non-clinical and preclinical testing.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">October 1, 2023</start_date>
    <completion_date type="Anticipated">August 31, 2024</completion_date>
    <primary_completion_date type="Anticipated">May 1, 2024</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>
      <primary_purpose>Other</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Successful implantation of Cook Zenith AAA Endovascular Graft using the 3D-GN&amp;C device</measure>
      <time_frame>During the procedure</time_frame>
      <description>Correct positioning of the endovascular stent graft confirmed by fluoroscopic imaging</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Delivery system placement in the intended location</measure>
      <time_frame>During the procedure</time_frame>
      <description>Distance between the fluoroscopy and digital subtraction angiography (mm)</description>
    </secondary_outcome>
    <other_outcome>
      <measure>Incidence of AE/SAE related to 3D-GN&amp;C device</measure>
      <time_frame>Through study completion, an average of 30 days</time_frame>
      <description>Incidence of SAE (serious adverse events) related to 3D-GNC device as well as incidence of non-SAE (non-Serious Adverse Events) related to 3D-GNC device</description>
    </other_outcome>
    <number_of_arms>1</number_of_arms>
    <enrollment type="Anticipated">3</enrollment>
    <condition>Abdominal Aortic Aneurysm</condition>
    <arm_group>
      <arm_group_label>Intervention</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Electromagnetic guidance and tracking as an adjunct to and confirmed by fluoroscopic imaging to be used with Cook Zenith Flex AAA Endovascular Graft.</description>
    </arm_group>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>3D Holographic Guidance, Navigation, and Control (3D GN&amp;C)</intervention_name>
      <description>Using electromagnetic (EM) guidance and tracking to precisely place a Cook Zenith Flex AAA bifurcated stent graft during EVAR. EM guidance and tracking is enabled using a system consisting of:&#xD;
  experimental 3D guidance, navigation, and control (3D-GNC) software developed by Centerline Biomedical, Inc., integrated with the company's FDA-cleared Intra-Operative Positioning System (IOPS),&#xD;
  FDA-cleared compatible sensorized guidewires added to the Cook Zenith Flex delivery system, and&#xD;
  3D visualization on the IOPS mobile cart monitor and 3D holographic visualization overlaid on the patient during the procedure using a head mounted display (HMD), the Microsoft HoloLens 2.</description>
      <arm_group_label>Intervention</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            1. The patient meets the instructions for use (IFU) for the 24-28 mm body Cook Zenith&#xD;
               Flex AAA bifurcated stent graft.&#xD;
  &#xD;
                 1. Adequate iliac/femoral access compatible with the required introduction system&#xD;
  &#xD;
                 2. Non aneurysmal infrarenal aortic segment (neck) proximal to the aneurysm:&#xD;
  &#xD;
               i. With a length of at least 15mm ii. With a diameter measured outer wall to outer&#xD;
               wall of no greater than 26mm and no less than 20mm iii. With an angle less than 60&#xD;
               degrees relative to the long access of the aneurysm and iv. With an angle less than 45&#xD;
               degrees relative to the axis of the suprarenal aorta c. Iliac artery distal fixation&#xD;
               site greater than 10mm in length and 7.5-20mm in diameter (measured outerwall to&#xD;
               outerwall).&#xD;
  &#xD;
            2. Male/female, aged ≥ 18&#xD;
  &#xD;
            3. Patient fulfilling criteria for needing endovascular repair of abdominal aortic&#xD;
               aneurysm according to routine clinical practice criteria of the participating center&#xD;
  &#xD;
            4. Women of childbearing potential must be non-pregnant, non-lactating, and not planning&#xD;
               to become pregnant during the course of the trial; and have a negative urine or serum&#xD;
               pregnancy test within 7 days prior to index procedure&#xD;
  &#xD;
            5. Provide written informed consent as applicable and defined by site country regulation&#xD;
  &#xD;
            6. Stated willingness to comply with all study procedures and availability for the&#xD;
               duration of the study&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
          An individual who meets any of the following criteria will be excluded from participation&#xD;
          in this study:&#xD;
  &#xD;
            1. Contraindications for Cook Zenith Flex Aortic endograft:&#xD;
  &#xD;
                 1. Patients with known sensitivities or allergies to stainless steel, polyester,&#xD;
                    solder (tin, silver), polypropylene, or gold&#xD;
  &#xD;
                 2. Patients with a systemic infection who may be at increased risk of endovascular&#xD;
                    graft infection&#xD;
  &#xD;
            2. Presence of electronic implants, e.g., cardiac pacemaker, AICD or nerve stimulator&#xD;
  &#xD;
            3. Presence of metallic implants above the knee, e.g., artificial hip&#xD;
  &#xD;
            4. Patients not willing or able to give informed consent&#xD;
  &#xD;
            5. Pregnant women&#xD;
  &#xD;
            6. Patients' inability to have a contrasted CT scan&#xD;
  &#xD;
            7. Current or planned participation in any other investigational drug or medical device&#xD;
               clinical study that has not completed primary endpoint(s) evaluation;&#xD;
  &#xD;
            8. Other medical, social, or psychological issues that in the opinion of the investigator&#xD;
               preclude the subjects from receiving this treatment, and the procedures and&#xD;
               evaluations pre- and posttreatment&#xD;
  &#xD;
            9. Anatomy outside of the IFU for a 24-28 mm Cook Zenith Flex AAA bifurcated stent graft&#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>Francis Caputo, MD</last_name>
      <role>Principal Investigator</role>
      <affiliation>The Cleveland Clinic</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Francis Caputo, MD</last_name>
      <phone>216-445-9580</phone>
      <email>caputof@ccf.org</email>
    </overall_contact>
    <location>
      <facility>
        <name>Cleveland Clinic</name>
        <address>
          <city>Cleveland</city>
          <state>Ohio</state>
          <zip>44195</zip>
          <country>United States</country>
        </address>
      </facility>
      <contact>
        <last_name>Francis Caputo, MD</last_name>
        <phone>216-445-9580</phone>
        <email>caputof@ccf.org</email>
      </contact>
      <contact_backup>
        <last_name>Yuki Kuramochi, BSN, RN</last_name>
        <phone>216-445-4063</phone>
        <email>kuramoy@ccf.org</email>
      </contact_backup>
    </location>
    <location_countries>
      <country>United States</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 9, 2023</study_first_submitted>
    <study_first_submitted_qc>August 18, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 23, 2023</study_first_posted>
    <last_update_submitted>August 28, 2023</last_update_submitted>
    <last_update_submitted_qc>August 28, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 30, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>AAA</keyword>
    <keyword>EVAR</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Aneurysm</mesh_term>
      <mesh_term>Aortic Aneurysm</mesh_term>
      <mesh_term>Aortic Aneurysm, Abdominal</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT06008613
  org study id: 23-753
  secondary id: 5R44HL139290-03
  nct id: NCT06008613
  lead sponsor: 
  collaborator: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: Yes
  This is an Early Feasibility Study to evaluate the usability, safety and functionality of 3D
        holographic guidance, navigation, and control (3D-GNC) as an adjunct to and confirmed by
        fluoroscopic imaging to be used with Cook Zenith Flex AAA Endovascular Graft.
  The goal of this clinical study is to evaluate the feasibility of using electromagnetic (EM)
        guidance and tracking to precisely place a Cook Zenith Flex AAA bifurcated stent graft during
        EVAR. EM guidance and tracking is enabled using a system consisting of the following: 1)
        experimental 3D guidance, navigation, and control (3D-GNC) software developed by Centerline
        Biomedical, Inc., integrated with the company's FDA-cleared Intra-Operative Positioning
        System (IOPS), 2) FDA-cleared compatible sensorized guidewires added to the Cook Zenith Flex
        delivery system and 3) 3D visualization on the IOPS mobile cart monitor and 3D holographic
        visualization overlaid on the patient during the procedure using a head mounted display
        (HMD), the Microsoft HoloLens 2. Planning and execution of each case will be major steps in
        demonstrating feasibility of the technology beyond non-clinical and preclinical testing.
  allocation: N/A
  intervention model: Single Group Assignment
  primary purpose: Other
  masking: None (Open Label)
  measure: Successful implantation of Cook Zenith AAA Endovascular Graft using the 3D-GN&C device
  time frame: During the procedure
  description: Correct positioning of the endovascular stent graft confirmed by fluoroscopic imaging
  measure: Delivery system placement in the intended location
  time frame: During the procedure
  description: Distance between the fluoroscopy and digital subtraction angiography (mm)
  measure: Incidence of AE/SAE related to 3D-GN&C device
  time frame: Through study completion, an average of 30 days
  description: Incidence of SAE (serious adverse events) related to 3D-GNC device as well as incidence of non-SAE (non-Serious Adverse Events) related to 3D-GNC device
  arm group label: Intervention
  arm group type: Experimental
  description: Electromagnetic guidance and tracking as an adjunct to and confirmed by fluoroscopic imaging to be used with Cook Zenith Flex AAA Endovascular Graft.
  intervention type: Device
  intervention name: 3D Holographic Guidance, Navigation, and Control (3D GN&C)
  description: Using electromagnetic (EM) guidance and tracking to precisely place a Cook Zenith Flex AAA bifurcated stent graft during EVAR. EM guidance and tracking is enabled using a system consisting of:
  experimental 3D guidance, navigation, and control (3D-GNC) software developed by Centerline Biomedical, Inc., integrated with the company's FDA-cleared Intra-Operative Positioning System (IOPS),
  FDA-cleared compatible sensorized guidewires added to the Cook Zenith Flex delivery system, and
  3D visualization on the IOPS mobile cart monitor and 3D holographic visualization overlaid on the patient during the procedure using a head mounted display (HMD), the Microsoft HoloLens 2.
  arm group label: Intervention
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Francis Caputo, MD
  role: Principal Investigator
  affiliation: The Cleveland Clinic
  last name: Francis Caputo, MD
  phone: 216-445-9580
  email: caputof@ccf.org
  facility: 
  contact: 
  contact backup: 
  country: United States
  responsible party type: Sponsor
  mesh term: Aneurysm
  mesh term: Aortic Aneurysm
  mesh term: Aortic Aneurysm, Abdominal
  sharing ipd: No