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Validation of Ultra Sound (US) Elastography (USE)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02773264
Recruitment Status : Recruiting
First Posted : May 16, 2016
Last Update Posted : November 4, 2020
Sponsor:
Information provided by (Responsible Party):
University of Zurich

Brief Summary:
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.

Condition or disease Intervention/treatment
Soft Tissue Lesions Device: Ultrasound

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.

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Study Type : Observational
Estimated Enrollment : 70 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Validation of Ultra Sound (US) Elastography for the Evaluation of Soft Tissue and Organ Lesions
Study Start Date : March 2016
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : December 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Ultrasound

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




Primary Outcome Measures :
  1. Non-Inferiority to conventional Ultrasound (conv. US) [ Time Frame: when scheduled for conv. US, 30minutes ]
    Value of US Elastography compared to conventional US


Secondary Outcome Measures :
  1. Superiority to conventional Ultrasound (conv. US) [ Time Frame: when scheduled for conv. US, 30minutes ]
    Value of US Elastography compared to conventional US



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patient scheduled for clinically indicated conventional Ultrasound examination
Criteria

Inclusion Criteria:

  • Patient scheduled for clinically indicated conventional Ultrasound examination

Exclusion Criteria:

  • Age < 18 years

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): NCT02773264


Contacts
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Contact: Thomas Frauenfelder, PD MD 0041442551111 thomas.frauenfelder@usz.ch
Contact: Marga Rominger, Prof. MD 0041442551111 marga.rominger@usz.ch

Locations
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Switzerland
University Hospital Zurich - Diagnostic Radiology Recruiting
Zurich, Switzerland, 8091
Contact: Thomas Frauenfelder, PD MD    0041442551111    thomas.frauenfelder@usz.ch   
Contact: Marga Rominger, Prof MD    0041442551111    marga.rominger@usz.ch   
Principal Investigator: Thomas Frauenfelder, PD MD         
Sub-Investigator: Marga Rominger, Prof MD         
Sponsors and Collaborators
University of Zurich
Investigators
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Principal Investigator: Thomas Frauenfelder, PD MD University Hospital Zurich, Institue of Diagnostic Radiology
Additional Information:
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Responsible Party: University of Zurich
ClinicalTrials.gov Identifier: NCT02773264    
Other Study ID Numbers: idr-us-001
First Posted: May 16, 2016    Key Record Dates
Last Update Posted: November 4, 2020
Last Verified: November 2020