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/NCT05963243</url>
    </required_header>
    <id_info>
      <org_study_id>IU2023_WH_02</org_study_id>
      <nct_id>NCT05963243</nct_id>
    </id_info>
    <brief_title>Automated Dating Scan Probe Pressure Data Collection Plan</brief_title>
    <official_title>A Volunteer Study to Collect Imaging Data for the Development of Identifying Probe Pressure as Part of ScanNav Assist Automated Dating Scan</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>IntelligentUltrasound Limited</agency>
        <agency_class>Industry</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>IntelligentUltrasound Limited</source>
    <oversight_info>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        The goal of this observational study is to collect data in the form of ultrasound recordings&#xD;
        from healthy volunteers, to aid the development of an Artificial Intelligence model that can&#xD;
        identify ultrasound probe pressure.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">August 2023</start_date>
    <completion_date type="Anticipated">December 2023</completion_date>
    <primary_completion_date type="Anticipated">December 2023</primary_completion_date>
    <study_type>Observational</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <observational_model>Case-Only</observational_model>
      <time_perspective>Prospective</time_perspective>
    </study_design_info>
    <primary_outcome>
      <measure>Ultrasound scan recordings</measure>
      <time_frame>6 months</time_frame>
      <description>Ultrasound scan recordings collected by the volunteer healthy participants of an abdominal self-scan.</description>
    </primary_outcome>
    <number_of_groups>1</number_of_groups>
    <enrollment type="Anticipated">25</enrollment>
    <condition>Ultrasound</condition>
    <arm_group>
      <arm_group_label>Healthy Volunteers</arm_group_label>
      <description>Healthy adult (18+ years old) volunteers</description>
    </arm_group>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Ultrasound Scans</intervention_name>
      <description>Ultrasound scans collected by experts in ultrasound-guided regional anaesthesia.</description>
      <arm_group_label>Healthy Volunteers</arm_group_label>
    </intervention>
    <eligibility>
      <study_pop>
        <textblock>
          Healthy adult volunteers from the South Wales region.&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            1. Male or female, at least 18 years of age;&#xD;
  &#xD;
            2. Able to comprehend and sign the Informed Consent prior to enrolment in the study.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            1. Aged &lt;18 years of age;&#xD;
  &#xD;
            2. Unwilling or unable to provide informed consent.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Steve Margetts, Dr</last_name>
      <role>Principal Investigator</role>
      <affiliation>Intelligent Ultrasound</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Megan Morecroft</last_name>
      <phone>02921 921 279</phone>
      <email>megan.morecroft@intelligentultrasound.com</email>
    </overall_contact>
    <verification_date>July 2023</verification_date>
    <study_first_submitted>July 19, 2023</study_first_submitted>
    <study_first_submitted_qc>July 19, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">July 27, 2023</study_first_posted>
    <last_update_submitted>July 19, 2023</last_update_submitted>
    <last_update_submitted_qc>July 19, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">July 27, 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/NCT05963243
  org study id: IU2023_WH_02
  nct id: NCT05963243
  lead sponsor: 
  is fda regulated drug: No
  is fda regulated device: No
  The goal of this observational study is to collect data in the form of ultrasound recordings
        from healthy volunteers, to aid the development of an Artificial Intelligence model that can
        identify ultrasound probe pressure.
  observational model: Case-Only
  time perspective: Prospective
  measure: Ultrasound scan recordings
  time frame: 6 months
  description: Ultrasound scan recordings collected by the volunteer healthy participants of an abdominal self-scan.
  arm group label: Healthy Volunteers
  description: Healthy adult (18+ years old) volunteers
  intervention type: Other
  intervention name: Ultrasound Scans
  description: Ultrasound scans collected by experts in ultrasound-guided regional anaesthesia.
  arm group label: Healthy Volunteers
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: Accepts Healthy Volunteers
  last name: Steve Margetts, Dr
  role: Principal Investigator
  affiliation: Intelligent Ultrasound
  last name: Megan Morecroft
  phone: 02921 921 279
  email: megan.morecroft@intelligentultrasound.com
  responsible party type: Sponsor
  sharing ipd: No