NCT01664780

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started May 2012

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2012

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

August 10, 2012

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 14, 2012

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2014

Completed
Last Updated

August 14, 2012

Status Verified

August 1, 2012

Enrollment Period

2.6 years

First QC Date

August 10, 2012

Last Update Submit

August 13, 2012

Conditions

Liver Transplantation

Keywords

standardvaluessharewave velocityin ARFI imaging

Study Arms (1)

Patients after liver transplantation

Device: ARFI imaging

Interventions

ARFI imagingDEVICE
Patients after liver transplantation

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients after orthotopic liver transplantation

You may qualify if:

  • Patients after orthotopic liver transplantation.

You may not qualify if:

  • Patients without status after orthotopic liver transplantation.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital of Erlangen, Dep. of Medicine 1

Erlangen, 91054, Germany

RECRUITING

MeSH Terms

Interventions

Elasticity Imaging Techniques

Intervention Hierarchy (Ancestors)

UltrasonographyDiagnostic ImagingDiagnostic Techniques and ProceduresDiagnosis

Study Officials

  • Dane Wildner, MD

    Dep. of Medicine 1, University of Erlangen-Nuremberg

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 10, 2012

First Posted

August 14, 2012

Study Start

May 1, 2012

Primary Completion

December 1, 2014

Study Completion

December 1, 2014

Last Updated

August 14, 2012

Record last verified: 2012-08

Locations

DE(1)