<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/NCT03008603</url>
  </required_header>
  <id_info>
    <org_study_id>CLN-001-00</org_study_id>
    <nct_id>NCT03008603</nct_id>
  </id_info>
  <brief_title>Evaluation of the Safety, Effectiveness &amp; Usability of the XACT Robotic System for Image Guided Percutaneous Procedures</brief_title>
  <official_title>Evaluation of the Safety, Effectiveness &amp; Usability of the XACT Robotic System for Image Guided Percutaneous Procedures</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Xact Robotics Ltd.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Xact Robotics Ltd.</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>
  </oversight_info>
  <brief_summary>
    <textblock>
      This is a prospective, single-arm study is to evaluate the safety, effectiveness and&#xD;
      usability of the XACT device. Subjects undergoing CT-guided, minimally invasive percutaneous&#xD;
      procedures in the interventional radiology suite, e.g., core biopsy, will participate in the&#xD;
      summary. Clinical accuracy will be the primary efficacy endpoint. Usability and safety will&#xD;
      also be evaluated.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is a prospective, single-arm study is to evaluate the safety, effectiveness and&#xD;
      usability of the XACT device. The study will be approved by the Institutional Review Board&#xD;
      (IRB) at each of the participating centers prior to patient enrollment.&#xD;
&#xD;
      Subjects undergoing CT-guided, minimally invasive percutaneous procedures in the&#xD;
      interventional radiology suite, e.g., core biopsy, fine needle aspiration (FNA), tumor&#xD;
      ablation, etc., and willing to sign an informed consent document will be screened for&#xD;
      compliance with the study inclusion and exclusion criteria.&#xD;
&#xD;
      A total of thirty (85) subjects will be enrolled in the study at 5 medical centers. The&#xD;
      intention is to recruit subjects, which will cover a variety of CT-guided interventional&#xD;
      procedures and a variety of different procedural tools that may be used with the device.&#xD;
      Investigators will screen patients based on the inclusion/exclusion criteria described below&#xD;
      and the subjects' demographic, general medical history, medical condition/indication,&#xD;
      coagulation factors, concomitant medications and vital signs will be obtained.&#xD;
&#xD;
      Clinical accuracy will be the primary efficacy endpoint and is defined as the ability to&#xD;
      place the instrument or procedural tool at a location suitable for the planned intervention.&#xD;
      The investigator will review the final instrument position on the post-placement CT images to&#xD;
      determine if the pre-operative planned target was reached. This information will be used to&#xD;
      calculate success rate.&#xD;
&#xD;
      Additionally, the usability of the XACT device will be evaluated using a rating scale by&#xD;
      assessing the ease of device setup, device operation, pre-operative planning, robot&#xD;
      positioning, guiding and needle advancement. The total time of the procedure will be&#xD;
      recorded, as will the number of CT scans performed and the radiation dose (DLP and CTDI). The&#xD;
      distance from the tip of the needle/tool to the target, once the XACT robot reaches the&#xD;
      pre-defined target will be measured in order to determine system accuracy in quantitative&#xD;
      terms using the system tools.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 4, 2018</start_date>
  <completion_date type="Actual">February 16, 2021</completion_date>
  <primary_completion_date type="Actual">February 16, 2021</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>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>The primary endpoint of the study is to evaluate the clinical accuracy of the XACT system.</measure>
    <time_frame>End of procedure</time_frame>
    <description>Clinical accuracy of the study will be determined by the ability of the XACT system to reach the pre-defined target in each procedure.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>The secondary endpoint of the study is to evaluate the usability of the XACT system under actual use clinical conditions.</measure>
    <time_frame>End of procedure</time_frame>
    <description>usability of the XACT device will be evaluated using a rating scale by assessing the ease of device setup, device operation, pre-operative planning, robot positioning, guiding and needle advancement.</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Incidence of Treatment-Emergent Adverse Events</measure>
    <time_frame>End of procedure</time_frame>
    <description>Safety of the XACT device will also be evaluated by reporting the incidence, severity and frequency of all Adverse Events (AE), related and unrelated to the device treatment.</description>
  </other_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">60</enrollment>
  <condition>CT-guided Minimally Invasive Procedures e.g., Biopsies</condition>
  <arm_group>
    <arm_group_label>Procedures with XACT Robotic System</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>CT-guided minimally invasive percutaneous procedures using the XACT Robotics system</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>XACT Robotic System</intervention_name>
    <description>The XACT device is a real-time, CT image guided, 3-dimensional robotic system. The XACT device is intended for use as an image guided positioning and steering system for insertion of clinical tools, such as biopsy needles, ablation needles, etc., during minimally invasive percutaneous procedures. The system is defined to guide (i.e., position and steer) the tool according to a predefined trajectory following a registration process between the device's coordinate system and real-time CT images.</description>
    <arm_group_label>Procedures with XACT Robotic System</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Men and women over 18 years of age&#xD;
&#xD;
          -  Subjects undergoing CT-guided, minimally invasive percutaneous procedures in the&#xD;
             interventional radiology suite, e.g., core biopsy, fine needle aspiration (FNA), tumor&#xD;
             ablation, etc.&#xD;
&#xD;
          -  Subject is capable and willing to provide informed consent.&#xD;
&#xD;
          -  Subject is capable and willing to adhere to the study procedures&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Subjects in whom the target is written 1 cm of a major blood vessel or major nerve.&#xD;
&#xD;
          -  Subject with lesions in the central and peripheral nervous system and the spine.&#xD;
&#xD;
          -  Subject with significant coagulopathy&#xD;
&#xD;
          -  Subjects with a preexisting conditions, which, in the opinion of the investigator, may&#xD;
             interfere with the conduct of the study&#xD;
&#xD;
          -  Subjects with an unstable medical condition, e.g. unstable hypertension, unstable&#xD;
             cardiac disease, etc.&#xD;
&#xD;
          -  Subjects who are uncooperative or cannot follow instructions&#xD;
&#xD;
          -  Subjects with a mental state that may preclude completion of the study procedure&#xD;
&#xD;
          -  Female subjects who are pregnant or nursing&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Lahey Hospital &amp; Medical Center</name>
      <address>
        <city>Burlington</city>
        <state>Massachusetts</state>
        <zip>01805</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hadassah Medical Center</name>
      <address>
        <city>Jerusalem</city>
        <zip>91120</zip>
        <country>Israel</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Israel</country>
    <country>United States</country>
  </location_countries>
  <verification_date>September 2021</verification_date>
  <study_first_submitted>December 28, 2016</study_first_submitted>
  <study_first_submitted_qc>December 28, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 2, 2017</study_first_posted>
  <last_update_submitted>September 20, 2021</last_update_submitted>
  <last_update_submitted_qc>September 20, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">September 22, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>CT-guided minimally invasive procedures</keyword>
  <keyword>Robot</keyword>
  <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/NCT03008603
org study id: CLN-001-00
nct id: NCT03008603
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: Yes
is unapproved device: Yes
This is a prospective, single-arm study is to evaluate the safety, effectiveness and
      usability of the XACT device. Subjects undergoing CT-guided, minimally invasive percutaneous
      procedures in the interventional radiology suite, e.g., core biopsy, will participate in the
      summary. Clinical accuracy will be the primary efficacy endpoint. Usability and safety will
      also be evaluated.
This is a prospective, single-arm study is to evaluate the safety, effectiveness and
      usability of the XACT device. The study will be approved by the Institutional Review Board
      (IRB) at each of the participating centers prior to patient enrollment.

      Subjects undergoing CT-guided, minimally invasive percutaneous procedures in the
      interventional radiology suite, e.g., core biopsy, fine needle aspiration (FNA), tumor
      ablation, etc., and willing to sign an informed consent document will be screened for
      compliance with the study inclusion and exclusion criteria.

      A total of thirty (85) subjects will be enrolled in the study at 5 medical centers. The
      intention is to recruit subjects, which will cover a variety of CT-guided interventional
      procedures and a variety of different procedural tools that may be used with the device.
      Investigators will screen patients based on the inclusion/exclusion criteria described below
      and the subjects' demographic, general medical history, medical condition/indication,
      coagulation factors, concomitant medications and vital signs will be obtained.

      Clinical accuracy will be the primary efficacy endpoint and is defined as the ability to
      place the instrument or procedural tool at a location suitable for the planned intervention.
      The investigator will review the final instrument position on the post-placement CT images to
      determine if the pre-operative planned target was reached. This information will be used to
      calculate success rate.

      Additionally, the usability of the XACT device will be evaluated using a rating scale by
      assessing the ease of device setup, device operation, pre-operative planning, robot
      positioning, guiding and needle advancement. The total time of the procedure will be
      recorded, as will the number of CT scans performed and the radiation dose (DLP and CTDI). The
      distance from the tip of the needle/tool to the target, once the XACT robot reaches the
      pre-defined target will be measured in order to determine system accuracy in quantitative
      terms using the system tools.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: The primary endpoint of the study is to evaluate the clinical accuracy of the XACT system.
time frame: End of procedure
description: Clinical accuracy of the study will be determined by the ability of the XACT system to reach the pre-defined target in each procedure.
measure: The secondary endpoint of the study is to evaluate the usability of the XACT system under actual use clinical conditions.
time frame: End of procedure
description: usability of the XACT device will be evaluated using a rating scale by assessing the ease of device setup, device operation, pre-operative planning, robot positioning, guiding and needle advancement.
measure: Incidence of Treatment-Emergent Adverse Events
time frame: End of procedure
description: Safety of the XACT device will also be evaluated by reporting the incidence, severity and frequency of all Adverse Events (AE), related and unrelated to the device treatment.
arm group label: Procedures with XACT Robotic System
arm group type: Experimental
description: CT-guided minimally invasive percutaneous procedures using the XACT Robotics system
intervention type: Device
intervention name: XACT Robotic System
description: The XACT device is a real-time, CT image guided, 3-dimensional robotic system. The XACT device is intended for use as an image guided positioning and steering system for insertion of clinical tools, such as biopsy needles, ablation needles, etc., during minimally invasive percutaneous procedures. The system is defined to guide (i.e., position and steer) the tool according to a predefined trajectory following a registration process between the device's coordinate system and real-time CT images.
arm group label: Procedures with XACT Robotic System
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
facility: 
facility: 
country: Israel
country: United States
responsible party type: Sponsor
sharing ipd: No