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/NCT05964439</url>
    </required_header>
    <id_info>
      <org_study_id>Pro00016558</org_study_id>
      <nct_id>NCT05964439</nct_id>
    </id_info>
    <brief_title>Augmented Reality Ultrasound Guidance</brief_title>
    <acronym>HoloUS</acronym>
    <official_title>HoloUS: Augmented Reality Visualization of Live Ultrasound Images Using HoloLens for Ultrasound-guided Procedures</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Children's National Research Institute</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Children's National Research Institute</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>No</is_us_export>
    </oversight_info>
    <brief_summary>
      <textblock>
        Many medical procedures are done with the aid of ultrasound imaging, but they remain&#xD;
        difficult to learn and perform. This study will use augmented reality technology for making&#xD;
        these procedures potentially more intuitive, easier, more precise, and safer.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Minimally invasive ultrasound-guided procedures are a mainstay of modern medicine and the&#xD;
        number of such procedures continues to grow. Safe, efficient, and precise execution of these&#xD;
        procedures requires a clear visualization of the target anatomy and the interventional device&#xD;
        (e.g., a needle). While sustained advances in ultrasound technology have led to greatly&#xD;
        enhanced visualization of the anatomy and the needle with high image quality, hand-eye&#xD;
        coordination of the practitioner continues to be a challenge. In order to properly position&#xD;
        the interventional device, the practitioner must alternate their attention between observing&#xD;
        the patient, advancing the needle, and viewing the ultrasound image on a separate screen.&#xD;
        This study's long-term goal is to develop an advanced visualization platform for&#xD;
        ultrasound-guided procedures to overcome this challenge by greatly simplifying hand-eye&#xD;
        coordination. The proposed platform will be developed using the latest advances in the&#xD;
        augmented reality (AR) technology. Through wearable, see-through AR glasses, the platform&#xD;
        will create a virtual display placed in the practitioner's field of view to show live&#xD;
        ultrasound images, registered with the transducer and the patient, in the form of a hologram.&#xD;
        The investigative team hypothesizes that such visualization will reduce the time of procedure&#xD;
        by 20%. This study is aimed providing the practitioner a more intuitive and efficient&#xD;
        platform to perform ultrasound-guided procedures and demonstrating improved efficiency&#xD;
        through user studies.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">March 11, 2022</start_date>
    <completion_date type="Anticipated">December 31, 2023</completion_date>
    <primary_completion_date type="Anticipated">December 31, 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>Other</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Task completion time</measure>
      <time_frame>The total time from when the needle first punctured the surface of the phantom to when fluid was successfully aspirated into the syringe, or 10 minutes, whichever occurred first</time_frame>
      <description>This outcome measure examines if the use of augmented reality leads to faster procedure.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Number of attempts</measure>
      <time_frame>From when the needle first punctured the surface of the phantom to when fluid was successfully aspirated into the syringe, or 10 minutes, whichever occurred first.</time_frame>
      <description>Number of times the user needed to successfully withdraw fluid from the vessel.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Number of head adjustments</measure>
      <time_frame>From when the needle first punctured the surface of the phantom to when fluid was successfully aspirated into the syringe, or 10 minutes, whichever occurred first.</time_frame>
      <description>Number of times the user moved or turned their head from its baseline position at the start of the procedure until task completion.</description>
    </secondary_outcome>
    <number_of_arms>1</number_of_arms>
    <enrollment type="Anticipated">44</enrollment>
    <condition>Paracentesis</condition>
    <arm_group>
      <arm_group_label>HoloUS app for ultrasound visualization</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>This is a single-arm study. Each study participant will evaluate HoloUS app and serve as their own control.</description>
    </arm_group>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>HoloUS app for ultrasound visualization</intervention_name>
      <description>Study participants will wear HoloLens see-through glasses and use the HoloUS app for ultrasound visualization in the conduct of a vascular access procedure in a phantom.</description>
      <arm_group_label>HoloUS app for ultrasound visualization</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Employees of the institution over 18 years.&#xD;
  &#xD;
            -  Volunteers participants who provide oral consent.&#xD;
  &#xD;
            -  For expert group, participants who have been trained to perform and are comfortable&#xD;
               with point-of-care ultrasound procedures (e.g., residents, fellows, attendings,&#xD;
               vascular access PAs/NPs).&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Any previous experience or training using the current version of the HoloUS app on the&#xD;
               HoloLens.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>100 Years</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Raj Shekhar, PhD</last_name>
      <role>Principal Investigator</role>
      <affiliation>Children's National Research Institute</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Raj Shekhar, PhD</last_name>
      <phone>202-476-1201</phone>
      <email>rshekhar@childrensnational.org</email>
    </overall_contact>
    <location>
      <facility>
        <name>Children's National Hospital</name>
        <address>
          <city>Washington</city>
          <state>District of Columbia</state>
          <zip>20010</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Raj Shekhar, PhD</last_name>
      </contact>
    </location>
    <location_countries>
      <country>United States</country>
    </location_countries>
    <verification_date>July 2023</verification_date>
    <study_first_submitted>July 18, 2023</study_first_submitted>
    <study_first_submitted_qc>July 25, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">July 28, 2023</study_first_posted>
    <last_update_submitted>July 25, 2023</last_update_submitted>
    <last_update_submitted_qc>July 25, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">July 28, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <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/NCT05964439
  org study id: Pro00016558
  nct id: NCT05964439
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: Yes
  is us export: No
  Many medical procedures are done with the aid of ultrasound imaging, but they remain
        difficult to learn and perform. This study will use augmented reality technology for making
        these procedures potentially more intuitive, easier, more precise, and safer.
  Minimally invasive ultrasound-guided procedures are a mainstay of modern medicine and the
        number of such procedures continues to grow. Safe, efficient, and precise execution of these
        procedures requires a clear visualization of the target anatomy and the interventional device
        (e.g., a needle). While sustained advances in ultrasound technology have led to greatly
        enhanced visualization of the anatomy and the needle with high image quality, hand-eye
        coordination of the practitioner continues to be a challenge. In order to properly position
        the interventional device, the practitioner must alternate their attention between observing
        the patient, advancing the needle, and viewing the ultrasound image on a separate screen.
        This study's long-term goal is to develop an advanced visualization platform for
        ultrasound-guided procedures to overcome this challenge by greatly simplifying hand-eye
        coordination. The proposed platform will be developed using the latest advances in the
        augmented reality (AR) technology. Through wearable, see-through AR glasses, the platform
        will create a virtual display placed in the practitioner's field of view to show live
        ultrasound images, registered with the transducer and the patient, in the form of a hologram.
        The investigative team hypothesizes that such visualization will reduce the time of procedure
        by 20%. This study is aimed providing the practitioner a more intuitive and efficient
        platform to perform ultrasound-guided procedures and demonstrating improved efficiency
        through user studies.
  allocation: N/A
  intervention model: Single Group Assignment
  primary purpose: Other
  masking: None (Open Label)
  measure: Task completion time
  time frame: The total time from when the needle first punctured the surface of the phantom to when fluid was successfully aspirated into the syringe, or 10 minutes, whichever occurred first
  description: This outcome measure examines if the use of augmented reality leads to faster procedure.
  measure: Number of attempts
  time frame: From when the needle first punctured the surface of the phantom to when fluid was successfully aspirated into the syringe, or 10 minutes, whichever occurred first.
  description: Number of times the user needed to successfully withdraw fluid from the vessel.
  measure: Number of head adjustments
  time frame: From when the needle first punctured the surface of the phantom to when fluid was successfully aspirated into the syringe, or 10 minutes, whichever occurred first.
  description: Number of times the user moved or turned their head from its baseline position at the start of the procedure until task completion.
  arm group label: HoloUS app for ultrasound visualization
  arm group type: Experimental
  description: This is a single-arm study. Each study participant will evaluate HoloUS app and serve as their own control.
  intervention type: Device
  intervention name: HoloUS app for ultrasound visualization
  description: Study participants will wear HoloLens see-through glasses and use the HoloUS app for ultrasound visualization in the conduct of a vascular access procedure in a phantom.
  arm group label: HoloUS app for ultrasound visualization
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 100 Years
  healthy volunteers: Accepts Healthy Volunteers
  last name: Raj Shekhar, PhD
  role: Principal Investigator
  affiliation: Children's National Research Institute
  last name: Raj Shekhar, PhD
  phone: 202-476-1201
  email: rshekhar@childrensnational.org
  facility: 
  status: Recruiting
  contact: 
  country: United States
  responsible party type: Sponsor
  sharing ipd: No