Clinical trial · Interventional
Safety & Feasibility of Ultrasound-assisted Non-invasive Measurement of Compressibility of the Thyroid Gland in Patients Scheduled for Surgical Removal
Safety & Feasibility of Ultrasound-assisted Non-invasive Measurement of Compressibility of the Thyroid Gland in Patients Scheduled for Surgical Removal (CPMX-Thyr)
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The thyroid gland plays an important role in hormone regulation however, it is often prone to nodules. This is common with nodules being found in up to 68% of people in a neck ultrasound, with likelihood increasing with age. However, only about 1 in 20 nodules turns out to be cancerous. Diagnosis of thyroid nodules starts with ultrasonic assessment, where specific features have been identified to estimate the risk of malignancy. If further examination is recommended, Fine Needle Aspiration (FNA) is performed. A needle is inserted into the nodule and the obtained subset of cells are then classified into 6 categories (Bethesda score) after examination under the microscope. While some Bethesda scores provide very accurate malignancy predictions, others like category 4, are unspecific, with risk of malignancy ranging from 25 to 40%. For these patients, about 75% are operated on even though they are not prospectively diagnosed. Soft tissue has certain physical properties, including its compressibility, which could be quantified by measuring the pressure required to deform it. It has been found that cancerous tissue is often harder than the surrounding healthy tissue. Compremium, a Swiss company which has its headquarters in Muri bei Bern, has developed a device that can be used to measure the compressibility of tissue, similarly to palpation but providing a quantitative assessment. The present study aims to investigate the feasibility and preliminary efficacy of this new technology to predict if thyroid nodules of patients scheduled for surgical removal based on FNA analysis are malignant or not.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Thyroid Nodule (Diagnosis) | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| CPMX1 | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- CPMX1 measurement
- description
- Measurement using investigational device CPMX 1 in addition to standard of care ultrasound.
- interventionNames
- Device: CPMX1
Primary outcomes (3)
- measure
- Device safety
- timeFrame
- up to 6 months
- description
- \- The practitioner will be asked to identify any new risks arising during the measurements using the investigational device and report these in the CRF.
- measure
- Device safety
- timeFrame
- Up to 6 months
- description
- Safety of the device shall be evaluated by systematically reporting device deficiencies (DDs), adverse device events (ADEs) and Serious adverse device events (SADEs) and by monitoring the frequency and incidence of these events.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Patients older than 18 years * Patients with a thyroid node * Patients with a Bethesda IV cytopathological diagnosis of this node * Informed consent documented by signature Exclusion Criteria: * Non-intact skin at the measurement site * BMI\>35kg/m2 * Patients unable to provide informed consent * Pregnant or breastfeeding women
References
Publications (0)
Data not yet available