ExanimationNCT07386782
Palpatory and Ultrasonographic Assessment of Tissue Compressibility: Validation and Learning Effects in Phantom Models
An observational study of Exanimation and Diagnostic Ultrasound, run by Insel Gruppe AG, University Hospital Bern at 1 site in Switzerland.
Trial summary
This validation study compares clinical palpation and ultrasonographic measurements of tissue compressibility using standardized phantom models. Operators with different levels of clinical and ultrasound experience perform repeated, blinded assessments across multiple sessions. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Exanimation, Diagnostic Ultrasound, Palpation
- What is being tested?
- Ultrasonographic Compression Measurment and Palpation of Standardized Phantom Models
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 40 participants
- Where
- 1 siteSwitzerland
- Study dates
- 31 Jan 2026to 31 May 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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
- Healthy volunteers accepted
- Adult, Older adult
Study population: Participants with different years of clinical experience and levels of experience in ultrasound diagnostics (medical students, residents, and attendings) will be included. Age >= 18 years.
Who may be able to join
- Medical professionals and medical students
Who cannot join
- Age <18 years
Trial locations and contacts
1 site in 1 country.
About this study
This validation study compares clinical palpation and ultrasonographic measurements of tissue compressibility using standardized phantom models. Operators with different levels of clinical and ultrasound experience perform repeated, blinded assessments across multiple sessions. The study evaluates accuracy, reliability, agreement between modalities, and learning effects over time, aiming to support standardized and more objective assessment of tissue compressibility in clinical practice.
- Conditions
- Exanimation, Diagnostic Ultrasound, Palpation
- Being tested
- Ultrasonographic Compression Measurment and Palpation of Standardized Phantom Models
- Keywords
- Exanimation, Diagnostic Ultrasound, Palpation
- Medical subject headings
- Coma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ultrasonographic Compression Measurment and Palpation of Standardized Phantom ModelsBehavioural
Repeated ultrasonographic compression measurements and palpation of standardized phantom models
What is being measured
The primary outcome is the main question the study is designed to answer.
Accuracy and reliability of palpation and ultrasonographic compression measurements
Intraoperator and interoperator accuracy and reliability of palpation and ultrasonographic compression measurements on two phantom models as intraclass correlation coefficient and linear mixed-effects model
Measured: Over 3 sessions, seperated by at least 1 day and at most 1 week (study duration: 3 days to 2 weeks)
Secondary outcomes (3)
Effect of operator characteristics on the measurement accuracy and reliability.
Operator characteristics (age, gender, level of experience) will be introduced as fixed effects in a linear mixed-effects model with a random effect for participants to account for repeated measurements
Measured: Over 3 sessions, seperated by at least 1 day and at most 1 week (study duration: 3 days to 2 weeks)
Assess the learning curve in palpation and ultrasound measurements
Changes in accuracy of both modalities using linear mixed-effects model with a random effect for participants to account for repeated measurements. To test possible confounding factors, they will be introduced as fixed effects.
Measured: Over 3 sessions, seperated by at least 1 day and at most 1 week (study duration: 3 days to 2 weeks)
Correlate the compression measurements with palpatory assessment
Correlation of both modalities using linear mixed-effects model with a random effect for participants to account for repeated measurements. To test possible confounding factors, they will be introduced as fixed effects.
Measured: Over 3 sessions, seperated by at least 1 day and at most 1 week (study duration: 3 days to 2 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Feb 2026
- Study start31 Jan 2026
- Primary completion30 Apr 2026 (estimated)
- Study completion31 May 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ExanimationStudies of the same condition, open and under way.
- More trials run by Insel Gruppe AG, University Hospital BernThe sponsor's other registered studies.
- 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
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Insel Gruppe AG, University Hospital Bern
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07386782
- Sponsor's protocol ID
- Req-2025-01655
- Status last verified
- Apr 2026
- First submitted
- 20 Jan 2026
- Last updated
- 17 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The data supporting this study's findings are available upon request from Samuel Tschopp, the corresponding author.
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Palpatory and Ultrasonographic Assessment of Tissue Compressibility: Validation and Learning Effects in Phantom Models
- ClinicalTrials.gov ID
- NCT07386782
- Acronym / sponsor ID
- Req-2025-01655
- Conditions
- Exanimation, Diagnostic Ultrasound, Palpation
- Keywords
- Exanimation, Diagnostic Ultrasound, Palpation
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Insel Gruppe AG, University Hospital BernUniversity, hospital or other
- Study start
- 31 Jan 2026 (actual)
- Primary completion
- 30 Apr 2026 (estimated)
- Study completion
- 31 May 2026 (estimated)
- First posted
- 4 Feb 2026 (actual)
- 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 validation study compares clinical palpation and ultrasonographic measurements of tissue compressibility using standardized phantom models. Operators with different levels of clinical and ultrasound experience perform repeated, blinded assessments across multiple sessions. The study evaluates accuracy, reliability, agreement between modalities, and learning effects over time, aiming to support standardized and more objective assessment of tissue compressibility in clinical practice.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Participants with different years of clinical experience and levels of experience in ultrasound diagnostics (medical students, residents, and attendings) will be included. Age >= 18 years.
Key inclusion criteria (1 listed)
- Medical professionals and medical students
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 |
|---|---|---|
| Ultrasonographic Compression Measurment and Palpation of Standardized Phantom ModelsRepeated ultrasonographic compression measurements and palpation of standardized phantom models | Behavioural | – |
Primary outcome
Accuracy and reliability of palpation and ultrasonographic compression measurements
Time frame: Over 3 sessions, seperated by at least 1 day and at most 1 week (study duration: 3 days to 2 weeks)
Intraoperator and interoperator accuracy and reliability of palpation and ultrasonographic compression measurements on two phantom models as intraclass correlation coefficient and linear mixed-effects model
3 secondary outcomes
Effect of operator characteristics on the measurement accuracy and reliability.
Time frame: Over 3 sessions, seperated by at least 1 day and at most 1 week (study duration: 3 days to 2 weeks)
Assess the learning curve in palpation and ultrasound measurements
Time frame: Over 3 sessions, seperated by at least 1 day and at most 1 week (study duration: 3 days to 2 weeks)
Correlate the compression measurements with palpatory assessment
Time frame: Over 3 sessions, seperated by at least 1 day and at most 1 week (study duration: 3 days to 2 weeks)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Apr 2026.
- Individual participant dataSharing planned: Yes. The data supporting this study's findings are available upon request from Samuel Tschopp, the corresponding author.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Exanimation and Diagnostic Ultrasound, run by Insel Gruppe AG, University Hospital Bern 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: under way, not looking for participants, as of the sponsor's last update on 17 Apr 2026. 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?
This study is still under way. Results are not available in the source record yet.
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?
Accuracy and reliability of palpation and ultrasonographic compression measurements (time frame: Over 3 sessions, seperated by at least 1 day and at most 1 week (study duration: 3 days to 2 weeks)). 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 17 Apr 2026.