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/NCT05992805</url>
    </required_header>
    <id_info>
      <org_study_id>IU2023_AG_11</org_study_id>
      <nct_id>NCT05992805</nct_id>
    </id_info>
    <brief_title>ScanNav Anatomy PNB Data Collection Study</brief_title>
    <official_title>ScanNav Anatomy PNB Data Collection Study</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>
        Study to gather additional data for AI-driven medical device, ScanNav Anatomy PNB.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Volunteer study to gather additional ultrasound training and/or validation data for&#xD;
        Artificial Intelligence (AI)-algorithms used in the medical device ScanNav Anatomy PNB.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">March 22, 2023</start_date>
    <completion_date type="Anticipated">December 31, 2023</completion_date>
    <primary_completion_date type="Anticipated">December 31, 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>Training and/or validation data (in the form of recorded ultrasound scans)</measure>
      <time_frame>6 months</time_frame>
      <description>Ultrasound scans to be used for training and/or validation of AI models developed in-house to assist ultrasound-guided regional anaesthesia.</description>
    </primary_outcome>
    <number_of_groups>1</number_of_groups>
    <enrollment type="Anticipated">40</enrollment>
    <condition>Data Collection</condition>
    <arm_group>
      <arm_group_label>Volunteer Participants</arm_group_label>
      <description>Volunteer participants being scanned by a qualified clinician using various ultrasound machines.</description>
    </arm_group>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>N/A - non-interventional study</intervention_name>
      <description>N/A - non-interventional study. Data collection only.</description>
      <arm_group_label>Volunteer Participants</arm_group_label>
    </intervention>
    <eligibility>
      <study_pop>
        <textblock>
          Healthy adult volunteers.&#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>
    <location>
      <facility>
        <name>Hodge House</name>
        <address>
          <city>Cardiff</city>
          <zip>CF10 1DY</zip>
          <country>United Kingdom</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Megan Morecroft</last_name>
        <phone>+44 (0) 2920 756534</phone>
        <email>megan.morecroft@intelligentultrasound.com</email>
      </contact>
      <investigator>
        <last_name>James Bowness, Dr</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location_countries>
      <country>United Kingdom</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>March 27, 2023</study_first_submitted>
    <study_first_submitted_qc>August 11, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 15, 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 15, 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/NCT05992805
  org study id: IU2023_AG_11
  nct id: NCT05992805
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  Study to gather additional data for AI-driven medical device, ScanNav Anatomy PNB.
  Volunteer study to gather additional ultrasound training and/or validation data for
        Artificial Intelligence (AI)-algorithms used in the medical device ScanNav Anatomy PNB.
  observational model: Case-Only
  time perspective: Prospective
  measure: Training and/or validation data (in the form of recorded ultrasound scans)
  time frame: 6 months
  description: Ultrasound scans to be used for training and/or validation of AI models developed in-house to assist ultrasound-guided regional anaesthesia.
  arm group label: Volunteer Participants
  description: Volunteer participants being scanned by a qualified clinician using various ultrasound machines.
  intervention type: Other
  intervention name: N/A - non-interventional study
  description: N/A - non-interventional study. Data collection only.
  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
  facility: 
  status: Recruiting
  contact: 
  investigator: 
  country: United Kingdom
  responsible party type: Sponsor
  sharing ipd: No