An observational study in Exanimation, Diagnostic Ultrasound and Palpation, sponsored by Insel Gruppe AG, University Hospital Bern. Active, not recruiting at 1 site in Switzerland. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-04-17.
Sponsored by Insel Gruppe AG, University Hospital Bern · Observational
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.
138 studies on the registry are indexed under Coma; 35 are open to participants now.
This study's planned enrollment of 40 is below the median of 100 across 58 observational studies indexed under Coma.
Browse Coma studies →Insel Gruppe AG, University Hospital Bern is the lead sponsor of 741 studies on the registry; 180 are open to participants now.
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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.
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Exclusion Criteria:
Repeated ultrasonographic compression measurements and palpation of standardized phantom models
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
Time frame: Over 3 sessions, seperated by at least 1 day and at most 1 week (study duration: 3 days to 2 weeks)
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
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
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.
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
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.
Time frame: Over 3 sessions, seperated by at least 1 day and at most 1 week (study duration: 3 days to 2 weeks)
Plan to share: Yes — The data supporting this study's findings are available upon request from Samuel Tschopp, the corresponding author.
Supporting information: Study protocol, Statistical analysis plan, Analytic code
Access criteria: The data supporting this study's findings are available upon request from Samuel Tschopp, the corresponding author.
No publications or documents are linked to this record.
Started Jan 2026 (actual). Primary completion is estimated for Apr 2026, 2 months after the start.
Of 24 observational studies under Coma, half reached primary completion within 34 months of starting (the median), counting those still running; a quarter within 14 and three quarters within 60. This study's planned 2 months is below that.
How these figures are worked out, and which studies are left out of them.
This study is active, not recruiting, as verified in Apr 2026. You cannot join it, but the record below documents what was studied.
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Insel Gruppe AG, University Hospital Bern →