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/NCT05963230</url>
    </required_header>
    <id_info>
      <org_study_id>IU2023_AG_12</org_study_id>
      <nct_id>NCT05963230</nct_id>
    </id_info>
    <brief_title>ScanNav Anatomy PNB FDA Data Collection Plan</brief_title>
    <official_title>ScanNav Anatomy PNB FDA Data Collection Plan</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>IntelligentUltrasound Limited</agency>
        <agency_class>Industry</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>IntelligentUltrasound Limited</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>
        To gather additional training and/or validation data (recorded ultrasound scans) for ScanNav&#xD;
        Anatomy PNB in the following categories:&#xD;
  &#xD;
          -  Femoral Nerve (Femoral)&#xD;
  &#xD;
          -  Interpectoral (PECS I) and pectoserratus (PECS II)&#xD;
  &#xD;
          -  Transversus abdominis plane (TAP)&#xD;
  &#xD;
          -  Serratus Plane (SP)&#xD;
  &#xD;
          -  Infra-inguinal Facia Iliaca (Infra-inguinal FI) Data will be collected in the form of&#xD;
             &quot;scenes&quot; (target block view) and &quot;non-scenes&quot; (areas adjacent to the target block view).&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Active, not recruiting</overall_status>
    <start_date type="Actual">July 1, 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 experts in ultrasound-guided regional anaesthesia.</description>
    </primary_outcome>
    <number_of_groups>1</number_of_groups>
    <enrollment type="Anticipated">40</enrollment>
    <condition>Ultrasound Recordings</condition>
    <arm_group>
      <arm_group_label>Volunteer Participants</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>Volunteer Participants</arm_group_label>
    </intervention>
    <eligibility>
      <study_pop>
        <textblock>
          Volunteers from the San Diego, California, USA region.&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Male or female, at least 18 years of age;&#xD;
  &#xD;
            -  Able to comprehend and sign the Informed Consent prior to enrolment in the study.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Aged &lt;18 years of age;&#xD;
  &#xD;
            -  Unwilling or unable to provide informed consent.&#xD;
  &#xD;
            -  Previous history of medical interventions that may affect the anatomy of the chosen&#xD;
               scan areas, e.g. hip replacements.&#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>James Bowness, Dr</last_name>
      <role>Principal Investigator</role>
      <affiliation>Intelligent Ultrasound</affiliation>
    </overall_official>
    <location>
      <facility>
        <name>Taylor Research</name>
        <address>
          <city>San Diego</city>
          <state>California</state>
          <zip>92108</zip>
          <country>United States</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>United States</country>
    </location_countries>
    <verification_date>August 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>August 11, 2023</last_update_submitted>
    <last_update_submitted_qc>August 11, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 14, 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/NCT05963230
  org study id: IU2023_AG_12
  nct id: NCT05963230
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  To gather additional training and/or validation data (recorded ultrasound scans) for ScanNav
        Anatomy PNB in the following categories:
  
          -  Femoral Nerve (Femoral)
  
          -  Interpectoral (PECS I) and pectoserratus (PECS II)
  
          -  Transversus abdominis plane (TAP)
  
          -  Serratus Plane (SP)
  
          -  Infra-inguinal Facia Iliaca (Infra-inguinal FI) Data will be collected in the form of
             "scenes" (target block view) and "non-scenes" (areas adjacent to the target block view).
  observational model: Case-Only
  time perspective: Prospective
  measure: Ultrasound scan recordings
  time frame: 6 months
  description: Ultrasound scan recordings collected by experts in ultrasound-guided regional anaesthesia.
  arm group label: Volunteer Participants
  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: Volunteer Participants
  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: James Bowness, Dr
  role: Principal Investigator
  affiliation: Intelligent Ultrasound
  facility: 
  country: United States
  responsible party type: Sponsor
  sharing ipd: No