<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/NCT01664780</url>
  </required_header>
  <id_info>
    <org_study_id>ARFI-UK Erlangen</org_study_id>
    <nct_id>NCT01664780</nct_id>
  </id_info>
  <brief_title>Acoustic Radiation Force Impulse Imaging (ARFI) in Patients After Liver Transplantation</brief_title>
  <official_title>Acoustic Radiation Force Impulse Imaging (ARFI) in Patients After Liver Transplantation</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Erlangen-Nürnberg Medical School</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Erlangen-Nürnberg Medical School</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Aims: Prospective evaluation of the applicability of acoustic radiation force impulse(ARFI)&#xD;
      imaging to assess liver fibrosis in patients after orthotopic liver transplantation.&#xD;
&#xD;
      Material and methods: We prospectively assess the performance of ARFI imaging in planned 100&#xD;
      patients after orthotopic liver transplantation. We evaluate shear wave velocity of the left&#xD;
      and right liver lobe with the convex array (6C1HD)ultrasound transducer and compare the&#xD;
      results with clinical data and B-mode criteria.&#xD;
&#xD;
      ARFI elastometry is an increasingly popular non-invasive method for the assessment of hepatic&#xD;
      fibrosis and cirrhosis. To date, ARFI technology has not been applied systematically in&#xD;
      patients after orthotopic liver transplantation. Therefore we want to establish standard&#xD;
      values in this population.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>May 2012</start_date>
  <completion_date type="Anticipated">December 2014</completion_date>
  <primary_completion_date type="Anticipated">December 2014</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Anticipated">100</enrollment>
  <condition>Liver Transplantation</condition>
  <arm_group>
    <arm_group_label>Patients after liver transplantation</arm_group_label>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>ARFI imaging</intervention_name>
    <arm_group_label>Patients after liver transplantation</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Patients after orthotopic liver transplantation&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients after orthotopic liver transplantation.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients without status after orthotopic liver transplantation.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Dane Wildner, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Dep. of Medicine 1, University of Erlangen-Nuremberg</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University Hospital of Erlangen, Dep. of Medicine 1</name>
      <address>
        <city>Erlangen</city>
        <zip>91054</zip>
        <country>Germany</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Dane Wildner, MD</last_name>
      <phone>0049 9131 8535250</phone>
      <email>dane.wildner@uk-erlangen.de</email>
    </contact>
    <contact_backup>
      <last_name>Steffen Zopf, MD</last_name>
      <phone>0049 9131 8535250</phone>
      <email>steffen.Zopf@uk-erlangen.de</email>
    </contact_backup>
    <investigator>
      <last_name>Deike Strobel, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Dane Wildner, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Steffen Zopf, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Germany</country>
  </location_countries>
  <verification_date>August 2012</verification_date>
  <study_first_submitted>August 10, 2012</study_first_submitted>
  <study_first_submitted_qc>August 13, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 14, 2012</study_first_posted>
  <last_update_submitted>August 13, 2012</last_update_submitted>
  <last_update_submitted_qc>August 13, 2012</last_update_submitted_qc>
  <last_update_posted type="Estimate">August 14, 2012</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>standard</keyword>
  <keyword>values</keyword>
  <keyword>share</keyword>
  <keyword>wave velocity</keyword>
  <keyword>in ARFI imaging</keyword>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


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/NCT01664780
org study id: ARFI-UK Erlangen
nct id: NCT01664780
lead sponsor: 
has dmc: No
Aims: Prospective evaluation of the applicability of acoustic radiation force impulse(ARFI)
      imaging to assess liver fibrosis in patients after orthotopic liver transplantation.

      Material and methods: We prospectively assess the performance of ARFI imaging in planned 100
      patients after orthotopic liver transplantation. We evaluate shear wave velocity of the left
      and right liver lobe with the convex array (6C1HD)ultrasound transducer and compare the
      results with clinical data and B-mode criteria.

      ARFI elastometry is an increasingly popular non-invasive method for the assessment of hepatic
      fibrosis and cirrhosis. To date, ARFI technology has not been applied systematically in
      patients after orthotopic liver transplantation. Therefore we want to establish standard
      values in this population.
observational model: Cohort
time perspective: Prospective
arm group label: Patients after liver transplantation
intervention type: Device
intervention name: ARFI imaging
arm group label: Patients after liver transplantation
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: No
last name: Dane Wildner, MD
role: Principal Investigator
affiliation: Dep. of Medicine 1, University of Erlangen-Nuremberg
facility: 
status: Recruiting
contact: 
contact backup: 
investigator: 
investigator: 
investigator: 
country: Germany
responsible party type: Sponsor