Soft Tissue LesionsUSENCT02773264
Validation of Ultra Sound (US) Elastography
An observational study of Soft Tissue Lesions, run by University of Zurich at 1 site in Switzerland.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Soft Tissue Lesions
- What is being tested?
- Ultrasound
- Type of treatment
- Medical device
- How many people
- 308 participants
- Where
- 1 siteSwitzerland
- Study dates
- 1 Mar 2016to 24 Jun 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patient scheduled for clinically indicated conventional Ultrasound examination
Who may be able to join
- Patient scheduled for clinically indicated conventional Ultrasound examination
Who cannot join
- Age < 18 years
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
University Hospital Zurich - Diagnostic Radiology
Zurich, 8091
About this study
Official title: 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.
Read the 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.
- Conditions
- Soft Tissue Lesions
- Being tested
- Ultrasound
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
UltrasoundDevice
Ultrasound Elastography of soft tissue and organ lesions
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Ultrasound |
What is being measured
The primary outcome is the main question the study is designed to answer.
Non-Inferiority to conventional Ultrasound (conv. US)
Value of US Elastography compared to conventional US
Measured: when scheduled for conv. US, 30minutes
Secondary outcomes (1)
Superiority to conventional Ultrasound (conv. US)
Value of US Elastography compared to conventional US
Measured: when scheduled for conv. US, 30minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 May 2016 (estimated)
- Study start1 Mar 2016
- Primary completion24 Jun 2024
- Study completion24 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Soft Tissue LesionsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 308 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Zurich
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Thomas Frauenfelder, PD MD, Principal investigator, University Hospital Zurich, Institue of Diagnostic Radiology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02773264
- Sponsor's protocol ID
- idr-us-001
- Acronym
- USE
- Status last verified
- Jun 2024
- First submitted
- 2 Jun 2015
- Last updated
- 1 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validation of Ultra Sound (US) Elastography for the Evaluation of Soft Tissue and Organ Lesions
- ClinicalTrials.gov ID
- NCT02773264
- Acronym / sponsor ID
- USE / idr-us-001
- Conditions
- Soft Tissue Lesions
- Study type
- Observational
- Recruitment status
- Terminated
- Enrolment
- 308 participants (actual)
- Lead sponsor
- University of ZurichUniversity, hospital or other
- Study start
- 1 Mar 2016
- Primary completion
- 24 Jun 2024 (actual)
- Study completion
- 24 Jun 2024 (actual)
- First posted
- 16 May 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| UltraSound Patients | – | Device: UltrasoundAll 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patient scheduled for clinically indicated conventional Ultrasound examination
Key inclusion criteria (1 listed)
- Patient scheduled for clinically indicated conventional Ultrasound examination
Key exclusion criteria (1 listed)
- Age < 18 years
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| UltrasoundUltrasound Elastography of soft tissue and organ lesions | Device | UltraSound Patients |
Primary outcome
Non-Inferiority to conventional Ultrasound (conv. US)
Time frame: when scheduled for conv. US, 30minutes
Value of US Elastography compared to conventional US
1 secondary outcome
Superiority to conventional Ultrasound (conv. US)
Time frame: when scheduled for conv. US, 30minutes
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jul 2024.
- Elastography in pancreatic solid tumours diagnoses.Link provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Thomas Frauenfelder, PD MD principal investigator
University Hospital Zurich, Institue of Diagnostic Radiology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Soft Tissue Lesions, run by University of Zurich at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 1 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early. Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Non-Inferiority to conventional Ultrasound (conv. US) (time frame: when scheduled for conv. US, 30minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jul 2024.