An interventional study of CPMX1 in Thyroid Nodule (Diagnosis), sponsored by Insel Gruppe AG, University Hospital Bern. Recruiting at 1 site in Switzerland. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-08-19.
Sponsored by Insel Gruppe AG, University Hospital Bern · Not applicable, Interventional, and Diagnostic
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.
207 studies on the registry are indexed under Thyroid Nodule; 64 are open to participants now.
This study's planned enrollment of 30 is below the median of 75 across 121 interventional studies indexed under Thyroid Nodule.
Browse Thyroid Nodule 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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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Measurement using investigational device CPMX 1 in addition to standard of care ultrasound.
Device: CPMX1
Compressibility of thyroid nodules using CPMX1 during pre surgery planning visit
Device safety
\- The practitioner will be asked to identify any new risks arising during the measurements using the investigational device and report these in the CRF.
Time frame: up to 6 months
Device safety
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.
Time frame: Up to 6 months
Device safety
The participant will be asked to rate the perceived pain scale after the examination with the investigational device using a patient questionaire (Numeric Rating Scale).
Time frame: Up to 6 months
Preliminary efficacy of CPMX1 compressability values to predict thyroid nodule malignancy.
Preliminary efficacy of compressibility values measured with the thyroid investigational system to predict a thyroid nodule's malignancy will be assessed by: 1. Computing discriminative ability and breaking down predictions into true and false positives and negatives 2. Quantification of the prospective number of surgeries if compressibility were used for clinical decision making. The thyroid's malignancy prediction will be determined by using the mean compressibility value over 5 consecutive measurements. Malignancy ground truth will be defined based on standard of care post-surgical histopathological results.
Time frame: 60 minutes
Plan to share: No
No publications or documents are linked to this record.
Started Aug 2025 (actual). Primary completion is estimated for Dec 2026, 16 months after the start.
Of 67 non-industry interventional studies with no phase under Thyroid Nodule, half reached primary completion within 30 months of starting (the median), counting those still running; a quarter within 13 and three quarters within 46. This study's planned 16 months is below that.
Counting every sponsor, half of 71 studies reached it within 30 months; a quarter within 14 and three quarters within 46.
How these figures are worked out, and which studies are left out of them.
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Insel Gruppe AG, University Hospital Bern →