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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01159717
Other study ID # EK 129/09
Secondary ID
Status Completed
Phase N/A
First received July 8, 2010
Last updated July 12, 2010
Start date January 2007
Est. completion date July 2010

Study information

Verified date July 2010
Source University Hospital, Basel, Switzerland
Contact n/a
Is FDA regulated No
Health authority Switzerland: Swissmedic
Study type Observational

Clinical Trial Summary

Retrospective comparison of complex cystic renal lesions which are found with computed tomography (CT) and were controlled with contrast enhanced ultrasound (CEUS).


Description:

All subjects receive an contrast enhanced CT due to different clinical indications. When a complex cystic renal lesion is found an evaluation with CEUS is performed. The CEUS protocol included a native baseline examination of both kidneys. After a bolus injection of 1.5 ml SonoVue (Bracco, Milano, Italy) an examination of the affected kidneys is performed over a time period of at least three minutes. An optional dose will be given when the initial examination is not conclusive, e. g. when the arterial phase is partly missed. When both examinations are done the lesions were classified using the Bosniak classification system and a comparison of both methods will be done.


Recruitment information / eligibility

Status Completed
Enrollment 35
Est. completion date July 2010
Est. primary completion date December 2008
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Finding of a complex cystic renal lesion

Exclusion Criteria:

- age < 18 y, gravity

Study Design

Observational Model: Case-Only, Time Perspective: Retrospective


Locations

Country Name City State
Switzerland Department of Radiology, University Hospital Basel, University of Basel Basel

Sponsors (1)

Lead Sponsor Collaborator
University Hospital, Basel, Switzerland

Country where clinical trial is conducted

Switzerland, 

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