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/NCT05983016</url>
    </required_header>
    <id_info>
      <org_study_id>H-20001116</org_study_id>
      <nct_id>NCT05983016</nct_id>
    </id_info>
    <brief_title>Automatic Abdominal Aortic Aneurysm Diameter Measurement</brief_title>
    <official_title>Automated Three-dimensional Ultrasound Bridges the Gap Between Novices and Experts in Diameter Assessment of Abdominal Aortic Aneurysms</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Natasha Monzon Svendsen</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>Philips Healthcare</agency>
        <agency_class>Industry</agency_class>
      </collaborator>
    </sponsors>
    <source>Rigshospitalet, Denmark</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>Yes</is_us_export>
    </oversight_info>
    <brief_summary>
      <textblock>
        Managing abdominal aortic aneurysms currently relies on diameter assessment with ultrasound.&#xD;
        Diameter reproducibility with two-dimensional ultrasound is challenging, and requires&#xD;
        experienced operators. A novel automatic three-dimensional ultrasound system has the&#xD;
        potential to facilitate more precise diameter measurements than two-dimensional ultrasound.&#xD;
        This study aimed to assess the variance of abdominal aortic aneurysm diameter measurements&#xD;
        among ultrasound novices and experts by comparing two-dimensional ultrasound with the&#xD;
        three-dimensional ultrasound system in a clinical setting.&#xD;
  &#xD;
        Ten patients under abdominal aortic aneurysm surveillance were examined by 29&#xD;
        ultrasound-operators: 13 experts and 16 novices. The experts were sonographers and physicians&#xD;
        highly experienced in abdominal aortic aneurysm ultrasound, and the novices were medical&#xD;
        students and junior residents with sparse ultrasound experience.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Completed</overall_status>
    <start_date type="Actual">January 15, 2022</start_date>
    <completion_date type="Actual">February 14, 2022</completion_date>
    <primary_completion_date type="Actual">February 14, 2022</primary_completion_date>
    <study_type>Observational</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <observational_model>Other</observational_model>
      <time_perspective>Prospective</time_perspective>
    </study_design_info>
    <primary_outcome>
      <measure>Abdominal aortic aneurysm measurement variance between novices and experts</measure>
      <time_frame>One week</time_frame>
      <description>The primary outcome was to test the variance of abdominal aortic aneurysm diameter measurements by comparing expert and novice ultrasound operators using conventional 2D-ultrasound and 3D-software assisted ultrasound.</description>
    </primary_outcome>
    <number_of_groups>1</number_of_groups>
    <enrollment type="Actual">10</enrollment>
    <condition>AAA - Abdominal Aortic Aneurysm</condition>
    <arm_group>
      <arm_group_label>Patients</arm_group_label>
      <description>All ten patients had their abdominal aortic aneurysm measured by experts and novices using both two-dimensional and three-dimensional ultrasound</description>
    </arm_group>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>Philips EPIQ-7, Philips Healthcare, Bothell, WA, USA</intervention_name>
      <description>All patients had their abdominal aortic aneurysm maximum anterior-posterior diameter estimated with two-dimensional ultrasound using a 5 MHz curved array transducer (Philips® C5-1 transducer, Philips Healthcare, Bothell, WA, USA).&#xD;
  After the acquisition, a three-dimensional ultrasound acquisition was performed with a 3D-matrix transducer (Philips® X6-1 transducers, Philips Healthcare, Bothell, WA, USA).</description>
      <arm_group_label>Patients</arm_group_label>
    </intervention>
    <eligibility>
      <study_pop>
        <textblock>
          The ten patients were selected from a large vascular surgery outpatient clinic.&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
          -Patients with an abdominal aortic aneurysm &gt; 3 cm.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>N/A</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <location>
      <facility>
        <name>Department of Vascular Surgery, Rigshospitalet</name>
        <address>
          <city>Copenhagen</city>
          <zip>2300</zip>
          <country>Denmark</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>Denmark</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 1, 2023</study_first_submitted>
    <study_first_submitted_qc>August 1, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 9, 2023</study_first_posted>
    <last_update_submitted>August 30, 2023</last_update_submitted>
    <last_update_submitted_qc>August 30, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 5, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor-Investigator</responsible_party_type>
      <investigator_affiliation>Rigshospitalet, Denmark</investigator_affiliation>
      <investigator_full_name>Natasha Monzon Svendsen</investigator_full_name>
      <investigator_title>MD</investigator_title>
    </responsible_party>
    <keyword>Ultrasound</keyword>
    <keyword>Three dimensional ultrasound</keyword>
    <keyword>Abdominal aortic aneurysm</keyword>
    <keyword>Sonography</keyword>
    <keyword>3D ultrasound</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Aneurysm</mesh_term>
      <mesh_term>Aortic Aneurysm</mesh_term>
      <mesh_term>Aortic Aneurysm, Abdominal</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>Undecided</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/NCT05983016
  org study id: H-20001116
  nct id: NCT05983016
  lead sponsor: 
  collaborator: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: Yes
  is us export: Yes
  Managing abdominal aortic aneurysms currently relies on diameter assessment with ultrasound.
        Diameter reproducibility with two-dimensional ultrasound is challenging, and requires
        experienced operators. A novel automatic three-dimensional ultrasound system has the
        potential to facilitate more precise diameter measurements than two-dimensional ultrasound.
        This study aimed to assess the variance of abdominal aortic aneurysm diameter measurements
        among ultrasound novices and experts by comparing two-dimensional ultrasound with the
        three-dimensional ultrasound system in a clinical setting.
  
        Ten patients under abdominal aortic aneurysm surveillance were examined by 29
        ultrasound-operators: 13 experts and 16 novices. The experts were sonographers and physicians
        highly experienced in abdominal aortic aneurysm ultrasound, and the novices were medical
        students and junior residents with sparse ultrasound experience.
  observational model: Other
  time perspective: Prospective
  measure: Abdominal aortic aneurysm measurement variance between novices and experts
  time frame: One week
  description: The primary outcome was to test the variance of abdominal aortic aneurysm diameter measurements by comparing expert and novice ultrasound operators using conventional 2D-ultrasound and 3D-software assisted ultrasound.
  arm group label: Patients
  description: All ten patients had their abdominal aortic aneurysm measured by experts and novices using both two-dimensional and three-dimensional ultrasound
  intervention type: Device
  intervention name: Philips EPIQ-7, Philips Healthcare, Bothell, WA, USA
  description: All patients had their abdominal aortic aneurysm maximum anterior-posterior diameter estimated with two-dimensional ultrasound using a 5 MHz curved array transducer (Philips® C5-1 transducer, Philips Healthcare, Bothell, WA, USA).
  After the acquisition, a three-dimensional ultrasound acquisition was performed with a 3D-matrix transducer (Philips® X6-1 transducers, Philips Healthcare, Bothell, WA, USA).
  arm group label: Patients
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: All
  minimum age: N/A
  maximum age: N/A
  healthy volunteers: Accepts Healthy Volunteers
  facility: 
  country: Denmark
  responsible party type: Sponsor-Investigator
  investigator affiliation: Rigshospitalet, Denmark
  investigator full name: Natasha Monzon Svendsen
  investigator title: MD
  mesh term: Aneurysm
  mesh term: Aortic Aneurysm
  mesh term: Aortic Aneurysm, Abdominal
  sharing ipd: Undecided