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NCT01664780 Clinical Trial

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

Liver Transplantation Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT01664780
Other study ID # ARFI-UK Erlangen
Secondary ID
Status Recruiting
Phase N/A
First received August 10, 2012
Last updated August 13, 2012
Start date May 2012
Est. completion date December 2014

Study information
Verified date August 2012
Source University of Erlangen-Nürnberg Medical School
Contact n/a
Is FDA regulated No
Health authority Germany: Ethics Commission
Study type Observational

Clinical Trial 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.

Recruitment information / eligibility
Status Recruiting
Enrollment 100
Est. completion date December 2014
Est. primary completion date December 2014
Accepts healthy volunteers No
Gender Both
Age group N/A and older
Eligibility Inclusion Criteria:

- Patients after orthotopic liver transplantation.

Exclusion Criteria:

- Patients without status after orthotopic liver transplantation.

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

Intervention

Device:
• ARFI imaging

Locations
Country Name City State
Germany University Hospital of Erlangen, Dep. of Medicine 1 Erlangen

Sponsors (1)
Lead Sponsor Collaborator
University of Erlangen-Nürnberg Medical School

Country where clinical trial is conducted

Germany, 

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