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Acoustic Radiation Force Impulse Imaging (ARFI) in Patients After Liver Transplantation

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ClinicalTrials.gov Identifier: NCT01664780
Recruitment Status : Unknown
Verified August 2012 by University of Erlangen-Nürnberg Medical School.
Recruitment status was:  Recruiting
First Posted : August 14, 2012
Last Update Posted : August 14, 2012
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:

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.


Condition or disease Intervention/treatment
Liver Transplantation Device: ARFI imaging

Study Design

Study Type : Observational
Estimated Enrollment : 100 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Acoustic Radiation Force Impulse Imaging (ARFI) in Patients After Liver Transplantation
Study Start Date : May 2012
Estimated Primary Completion Date : December 2014
Estimated Study Completion Date : December 2014

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Groups and Cohorts

Group/Cohort Intervention/treatment
Patients after liver transplantation Device: ARFI imaging


Outcome Measures

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients after orthotopic liver transplantation
Criteria

Inclusion Criteria:

  • Patients after orthotopic liver transplantation.

Exclusion Criteria:

  • Patients without status after orthotopic liver transplantation.
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01664780


Locations
Germany
University Hospital of Erlangen, Dep. of Medicine 1 Recruiting
Erlangen, Germany, 91054
Contact: Dane Wildner, MD    0049 9131 8535250    dane.wildner@uk-erlangen.de   
Contact: Steffen Zopf, MD    0049 9131 8535250    steffen.Zopf@uk-erlangen.de   
Sub-Investigator: Deike Strobel, MD         
Principal Investigator: Dane Wildner, MD         
Principal Investigator: Steffen Zopf, MD         
Sponsors and Collaborators
University of Erlangen-Nürnberg Medical School
Investigators
Principal Investigator: Dane Wildner, MD Dep. of Medicine 1, University of Erlangen-Nuremberg
More Information

Responsible Party: University of Erlangen-Nürnberg Medical School
ClinicalTrials.gov Identifier: NCT01664780     History of Changes
Other Study ID Numbers: ARFI-UK Erlangen
First Posted: August 14, 2012    Key Record Dates
Last Update Posted: August 14, 2012
Last Verified: August 2012

Keywords provided by University of Erlangen-Nürnberg Medical School:
standard
values
share
wave velocity
in ARFI imaging