Safety and feasibility of ultrasound-assisted non-invasive measurement of thyroid compressibility in patients scheduled for surgical removal.

Summary description of the study

During their visit for surgical planning, we will conduct an examination using the medical device (manufactured by Compremium) on the patients included in the study. The device is based on ultrasound technology coupled with a pressure sensor, providing a quick, non-invasive, and painless way to see what is happening inside the body. Five consecutive measurements will be performed by a physician. The ultrasound examination will be conducted while lying down and will last three minutes. During the measurement, an ascending pressure will be applied to the neck, comparable to the pressure experienced when you press your hand flat against the neck. This way, the degree of compression of the nodule will be measured. Although the measurement should not cause pain, patients will be asked to rate any discomfort felt immediately after the procedure on a scale from 0 (no pain) to 10 (worst imaginable pain). The feasibility of the procedure will also be assessed by the physicians using two questionnaires: a usability questionnaire for each participant and general feedback at the end of the study. The safety of the device will be evaluated by recording all issues (e.g., device failures, side effects, or serious problems) and their frequency. Physicians will also be asked to report any new risks that arise from using the device. One to six months later, patients will return to the hospital for their surgery, and we will use the final diagnosis after analyzing the removed tissue to assess whether the compressibility of the thyroid nodule could be used in the future to better predict malignancy and avoid unnecessary surgeries. The study will be conducted with approximately 30 patients and should last a maximum of 18 months.

(BASEC)

Intervention under investigation

This clinical study will be conducted on patients who have received a Bethesda IV cytopathological diagnosis of a thyroid nodule from the endocrinology outpatient clinic and are scheduled for surgical removal. During this study, patients will receive standard medical care (examination and treatment), regardless of the results of the thyroid examination with the medical device. The measurement of nodule compressibility with the medical device will be performed by a physician on each study participant. Under ultrasound and real-time pressure measurement, the nodule of interest will be localized and gradually compressed by the examiner using the CP probe and feedback on the extrinsically applied pressure. The measurement process will be repeated five times in a row for each patient to increase robustness. A cut video of the ultrasound image and the simultaneous pressure values during the compression process will be automatically recorded. The degree of compression is called CP Value and could indicate whether the nodule is cancerous. The obtained results will be compared with postoperative histopathological analyses.

(BASEC)

Disease under investigation

Thyroid cancer

(BASEC)

Sponsor

Inselspital

(BASEC)

Name of the authorising ethics committee (for multicentre studies, only the lead committee)

Ethics Committee Bern

(BASEC)

Date of authorisation

28.05.2025

(BASEC)

Results of the trial