Validation of Ultra Sound (US) Elastography (USE)

June 28, 2024 updated by: University of Zurich

Validation of Ultra Sound (US) Elastography for the Evaluation of Soft Tissue and Organ Lesions

This is a prospective, single-center, non-randomised, non-blinded trial with US Elastography of Patients referred to our institution to assess soft tissue and organ lesions. All patients will undergo next to the clinical indicated conventional US-examination, US Elastography after informed consent. After completion of these three examinations, the participation in the study is completed.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

The investigators propose UltraSound Elastography as an imaging method which allows for a better evaluation of soft tissue and organ lesions compared to the conventional US modalities used nowadays in the dayly clinical routine.

This is a prospective, single-center, non-randomised, non-blinded trial with US Elastography of Patients referred to our institution to assess soft tissue and organ lesions. All patients will undergo next to the clinical indicated conventional US-examination, US Elastography after informed consent. After completion of these three examinations, the participation in the study is completed.

Study Type

Observational

Enrollment (Actual)

308

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Switzerland
      • Zurich, Switzerland, 8091
        • University Hospital Zurich - Diagnostic Radiology

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

Patient scheduled for clinically indicated conventional Ultrasound examination

Description

Inclusion Criteria:

  • Patient scheduled for clinically indicated conventional Ultrasound examination

Exclusion Criteria:

  • Age < 18 years

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
UltraSound Patients
All patients will undergo next to the clinical indicated conventional US-examination, US Elastography after informed consent. After completion of these three examinations, the participation in the study is completed.
Device: Ultrasound
Ultrasound Elastography of soft tissue and organ lesions

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Non-Inferiority to conventional Ultrasound (conv. US)
Time Frame: when scheduled for conv. US, 30minutes
Value of US Elastography compared to conventional US
when scheduled for conv. US, 30minutes

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Superiority to conventional Ultrasound (conv. US)
Time Frame: when scheduled for conv. US, 30minutes
Value of US Elastography compared to conventional US
when scheduled for conv. US, 30minutes

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Zurich

Investigators

  • Principal Investigator: Thomas Frauenfelder, PD MD, University Hospital Zurich, Institue of Diagnostic Radiology

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2016

Primary Completion (Actual)

June 24, 2024

Study Completion (Actual)

June 24, 2024

Study Registration Dates

First Submitted

June 2, 2015

First Submitted That Met QC Criteria

May 11, 2016

First Posted (Estimated)

May 16, 2016

Study Record Updates

Last Update Posted (Actual)

July 1, 2024

Last Update Submitted That Met QC Criteria

June 28, 2024

Last Verified

June 1, 2024

More Information

Terms related to this study

Other Study ID Numbers

  • idr-us-001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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