Validation of Ultra Sound (US) Elastography

Terminated

• Conditions: Soft Tissue Lesions
• Interventions: Device: Ultrasound

• Registration Number: NCT02773264
• Lead Sponsor: 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.

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 Timeline

• Study First Submitted: 2015-06-02
• Study Start: 2016-03-01
• Study First Submitted QC: 2016-05-11
• Study First Posted: 2016-05-16
• Status Verified: 2024-06
• Primary Completion: 2024-06-24
• Study Completion: 2024-06-24
• Last Update Submitted: 2024-06-28
• Last Update Posted: 2024-07-01

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 308

Inclusion Criteria

• Patient scheduled for clinically indicated conventional Ultrasound examination

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Exclusion Criteria

• Age < 18 years

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
UltraSound Patients	Ultrasound	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.

Primary Outcome Measures

Name	Time	Method
Non-Inferiority to conventional Ultrasound (conv. US)	when scheduled for conv. US, 30minutes	Value of US Elastography compared to conventional US

Secondary Outcome Measures

Name	Time	Method
Superiority to conventional Ultrasound (conv. US)	when scheduled for conv. US, 30minutes	Value of US Elastography compared to conventional US

Trial Locations

Locations (1)

University Hospital Zurich - Diagnostic Radiology; 🇨🇭 Zurich, Switzerland