Safety & Feasibility of Ultrasound-assisted Non-invasive Measurement of Compressibility of the Thyroid Gland in Patients Scheduled for Surgical Removal

NCT ID: NCT07102264

Last Updated: 2025-08-19

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-08-15
• Study Completion Date: 2026-12-16

Brief Summary

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

Thyroid Nodule (Diagnosis)

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

CPMX1 measurement

Measurement using investigational device CPMX 1 in addition to standard of care ultrasound.

Group Type: EXPERIMENTAL

CPMX1

Intervention Type: DEVICE

Compressibility of thyroid nodules using CPMX1 during pre surgery planning visit

Interventions

CPMX1

Compressibility of thyroid nodules using CPMX1 during pre surgery planning visit

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Insel Gruppe AG, University Hospital Bern

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

PD Dr. med. Urs Borner

Role: PRINCIPAL_INVESTIGATOR

Insel Gruppe AG, University Hospital Bern

Locations

Department of Oto-Rhino-Laryngology, Head and Neck surgery Inselspital, Bern University Hospital and University of Bern

Bern, , Switzerland

Site Status: RECRUITING

Countries

Switzerland

Central Contacts

PD Dr. med. Urs Borner

Role: CONTACT

urs.borner@insel.ch

+41(0)316324174

Facility Contacts

PD Dr. med. Urs Borner

Role: primary

urs.borner@insel.ch

+41 (0)31 632 4174

Other Identifiers

CPMX-Thyr

Identifier Type: -

Identifier Source: org_study_id