Validation of Ultra Sound (US) Elastography

NCT02773264 | Terminated

• 1 other identifier: idr-us-001
• Study Type: observational
• Target: 308
• Locations: 1 country
• Sites: 1

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.

Conditions

Soft Tissue Lesions

Outcome Measures

Primary Outcomes (1)

• Non-Inferiority to conventional Ultrasound (conv. US)

  Value of US Elastography compared to conventional US

  when scheduled for conv. US, 30minutes

Secondary Outcomes (1)

• Superiority to conventional Ultrasound (conv. US)

  when scheduled for conv. US, 30minutes

Study Arms (1)

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

Interventions

Ultrasound DEVICE

Ultrasound Elastography of soft tissue and organ lesions

UltraSound Patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patient scheduled for clinically indicated conventional Ultrasound examination

You may qualify if:

• Patient scheduled for clinically indicated conventional Ultrasound examination

You may not qualify if:

• Age \< 18 years

Sponsors & Collaborators

• University of Zurich: lead

Study Sites (1)

University Hospital Zurich - Diagnostic Radiology

Zurich, 8091, Switzerland

Location

Related Links

• Elastography in pancreatic solid tumours diagnoses.

MeSH Terms

Interventions

Ultrasonography

Intervention Hierarchy (Ancestors)

Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis

Study Officials

• Thomas Frauenfelder, PD MD

  University Hospital Zurich, Institue of Diagnostic Radiology

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: June 2, 2015
• First Posted: May 16, 2016
• Study Start: March 1, 2016
• Primary Completion: June 24, 2024
• Study Completion: June 24, 2024
• Last Updated: July 1, 2024

Record last verified: 2024-06

Locations

CH (1)