<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/NCT02995603</url>
  </required_header>
  <id_info>
    <org_study_id>Nano-X V1</org_study_id>
    <nct_id>NCT02995603</nct_id>
  </id_info>
  <brief_title>Patient Experience and Acceptance of Horizontal Rotation</brief_title>
  <acronym>Nano-X</acronym>
  <official_title>Nano-X: Patient Experience and Acceptance of Horizontal Rotation</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Sydney</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Prince of Wales Hospital, Sydney</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Sydney</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Patients will complete validated psychometric questionnaires to quantify their experience of&#xD;
      being rotated at different speeds using the Nano-X patient rotation system.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Study participants will be asked to attend the clinic on two separate occasions. Each session&#xD;
      will last less than one hour. Patients will be asked to complete validated psychometric&#xD;
      surveys assessing 1) their level of claustrophobia, 2) their level of anxiety and 3) their&#xD;
      (baseline) motion sickness, before and after each session. They will then be rotated 3-4&#xD;
      times on the Nano-X patient rotation system, at varying speeds ranging from 6°/sec to&#xD;
      45°/sec. Each rotation will be designed to simulate a typical radiotherapy treatment; that is&#xD;
      9 angles, pausing for around 30 seconds at each angle. Straight after each rotation, patients&#xD;
      will again complete the questionnaire assessing their anxiety levels and motion sickness.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">December 14, 2019</start_date>
  <completion_date type="Anticipated">December 2023</completion_date>
  <primary_completion_date type="Anticipated">June 2023</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>Basic Science</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in level of patient anxiety following rotation in the Nano-X Patient Rotation System</measure>
    <time_frame>1 hour</time_frame>
    <description>Comparison of mean scores of Short Form State/Trait Anxiety Inventory (STAI) Questionnaire outcomes before and after being rotated in the Nano-X Patient Rotation System</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in level of patient motion sickness following rotation in the Nano-X Patient Rotation System</measure>
    <time_frame>1 hour</time_frame>
    <description>Comparison of mean scores of Fast Motion Sickness Test (FMS) Questionnaire outcomes before and after being rotated in the Nano-X Patient Rotation</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Correlation between claustrophobia and the change in anxiety and motion sickness of patients following rotation in the Nano-X Patient Rotation System</measure>
    <time_frame>1 year</time_frame>
    <description>Correlation between Claustrophobia Questionnaire (CLQ) scores prior to study participation on the anxiety and motion sickness results measured in Outcome 1 and Outcome 2</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">100</enrollment>
  <condition>Cancer</condition>
  <arm_group>
    <arm_group_label>Patient rotation</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients will be rotated horizontally, using the Nano-X patient rotation system, and asked to complete validated questionnaires to quantify their experience.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Nano-X patient rotation</intervention_name>
    <description>Patients are required to completed validated questionnaires to quantify their experience of horizontal rotation.</description>
    <arm_group_label>Patient rotation</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. A diagnosis of cancer, any stage&#xD;
&#xD;
          2. ≥18 years of age&#xD;
&#xD;
          3. Eastern Cooperative Oncology Group (ECOG) status 0-2&#xD;
&#xD;
          4. Currently or previously being treated with radiotherapy&#xD;
&#xD;
          5. Any prior therapy allowed&#xD;
&#xD;
          6. Willing and able to comply with all study requirements&#xD;
&#xD;
          7. Must be able to read and complete questionnaires in English&#xD;
&#xD;
          8. Signed, written informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Pregnant women&#xD;
&#xD;
          2. Mentally impaired patients or patients for whom attaining informed consent would be&#xD;
             difficult (including language barriers)&#xD;
&#xD;
          3. Severe vertigo or recent diagnosis of Benign Paroxysmal Positioning Vertigo&#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>Paul Keall, Prof</last_name>
    <role>Study Chair</role>
    <affiliation>University of Sydney</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Shona Silvester</last_name>
    <phone>+61 2 86271185</phone>
    <email>shona.silvester@sydney.edu.au</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Natalie Plant, Masters</last_name>
    <phone>+61 2 86271133</phone>
    <email>natalie.plant@sydney.edu.au</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Prince of Wales Hospital</name>
      <address>
        <city>Randwick</city>
        <state>New South Wales</state>
        <zip>2031</zip>
        <country>Australia</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Michael Jackson, A/Prof</last_name>
      <phone>+61 2 9382 8873</phone>
      <email>michael.jackson2@health.nsw.gov.au</email>
    </contact>
    <contact_backup>
      <last_name>Meg Schneider, BN</last_name>
      <phone>+61 2 9382 2507</phone>
      <email>meg.schneider@health.nsw.gov.au</email>
    </contact_backup>
  </location>
  <location_countries>
    <country>Australia</country>
  </location_countries>
  <verification_date>November 2022</verification_date>
  <study_first_submitted>December 7, 2016</study_first_submitted>
  <study_first_submitted_qc>December 13, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 16, 2016</study_first_posted>
  <last_update_submitted>November 4, 2022</last_update_submitted>
  <last_update_submitted_qc>November 4, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">November 7, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Radiotherapy</keyword>
  <keyword>Rotation</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/NCT02995603
org study id: Nano-X V1
nct id: NCT02995603
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Patients will complete validated psychometric questionnaires to quantify their experience of
      being rotated at different speeds using the Nano-X patient rotation system.
Study participants will be asked to attend the clinic on two separate occasions. Each session
      will last less than one hour. Patients will be asked to complete validated psychometric
      surveys assessing 1) their level of claustrophobia, 2) their level of anxiety and 3) their
      (baseline) motion sickness, before and after each session. They will then be rotated 3-4
      times on the Nano-X patient rotation system, at varying speeds ranging from 6°/sec to
      45°/sec. Each rotation will be designed to simulate a typical radiotherapy treatment; that is
      9 angles, pausing for around 30 seconds at each angle. Straight after each rotation, patients
      will again complete the questionnaire assessing their anxiety levels and motion sickness.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Basic Science
masking: None (Open Label)
measure: Change in level of patient anxiety following rotation in the Nano-X Patient Rotation System
time frame: 1 hour
description: Comparison of mean scores of Short Form State/Trait Anxiety Inventory (STAI) Questionnaire outcomes before and after being rotated in the Nano-X Patient Rotation System
measure: Change in level of patient motion sickness following rotation in the Nano-X Patient Rotation System
time frame: 1 hour
description: Comparison of mean scores of Fast Motion Sickness Test (FMS) Questionnaire outcomes before and after being rotated in the Nano-X Patient Rotation
measure: Correlation between claustrophobia and the change in anxiety and motion sickness of patients following rotation in the Nano-X Patient Rotation System
time frame: 1 year
description: Correlation between Claustrophobia Questionnaire (CLQ) scores prior to study participation on the anxiety and motion sickness results measured in Outcome 1 and Outcome 2
arm group label: Patient rotation
arm group type: Experimental
description: Patients will be rotated horizontally, using the Nano-X patient rotation system, and asked to complete validated questionnaires to quantify their experience.
intervention type: Device
intervention name: Nano-X patient rotation
description: Patients are required to completed validated questionnaires to quantify their experience of horizontal rotation.
arm group label: Patient rotation
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Paul Keall, Prof
role: Study Chair
affiliation: University of Sydney
last name: Shona Silvester
phone: +61 2 86271185
email: shona.silvester@sydney.edu.au
last name: Natalie Plant, Masters
phone: +61 2 86271133
email: natalie.plant@sydney.edu.au
facility: 
status: Recruiting
contact: 
contact backup: 
country: Australia
responsible party type: Sponsor
sharing ipd: No