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NCT Number: NCT07386782

Palpatory and Ultrasonographic Assessment of Tissue Compressibility: Validation and Learning Effects in Phantom Models

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.

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This study is active but is not currently recruiting participants.

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Key information

Conditions

Exanimation Coma Consciousness Disorders Diagnostic Ultrasound Nervous System Diseases Neurobehavioral Manifestations Neurologic Manifestations Palpation Pathological Conditions, Signs and Symptoms Signs and Symptoms Unconsciousness

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Inselspital Bern

Bern, 3010, Switzerland

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Medical professionals and medical students

Exclusion criteria

  • Age <18 years

Treatment and study plan

Ultrasonographic Compression Measurment and Palpation of Standardized Phantom Models

Behavioral

Repeated ultrasonographic compression measurements and palpation of standardized phantom models

Primary outcomes

  1. 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

Secondary outcomes

  1. 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)

    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

  2. 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)

    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.

  3. 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)

    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.

Sponsors and collaborators

Lead sponsor

Insel Gruppe AG, University Hospital Bern

Other

Registry information

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Feb 4, 2026
Registry last updated
Apr 17, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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