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

NCT07102264 | Recruiting

• 1 other identifier: CPMX-Thyr
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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)

Outcome Measures

Primary Outcomes (3)

• 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.

  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.

  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).

  Up to 6 months

Secondary Outcomes (1)

• Preliminary efficacy of CPMX1 compressability values to predict thyroid nodule malignancy.

  60 minutes

Study Arms (1)

CPMX1 measurement

EXPERIMENTAL

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

Device: CPMX1

Interventions

CPMX1 DEVICE

Compressibility of thyroid nodules using CPMX1 during pre surgery planning visit

CPMX1 measurement

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Non-intact skin at the measurement site
• BMI\>35kg/m2
• Patients unable to provide informed consent
• Pregnant or breastfeeding women

Sponsors & Collaborators

• Insel Gruppe AG, University Hospital Bern: lead

Study Sites (1)

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

Bern, 3010, Switzerland

RECRUITING

MeSH Terms

Conditions

Thyroid Nodule; Disease

Condition Hierarchy (Ancestors)

Thyroid Neoplasms; Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Head and Neck Neoplasms; Endocrine System Diseases; Thyroid Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• PD Dr. med. Urs Borner

  Insel Gruppe AG, University Hospital Bern

  PRINCIPAL INVESTIGATOR

Central Study Contacts

PD Dr. med. Urs Borner

CONTACT

+41(0)316324174; urs.borner@insel.ch

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 18, 2025
• First Posted: August 3, 2025
• Study Start: August 15, 2025
• Primary Completion (Estimated): December 16, 2026
• Study Completion (Estimated): December 16, 2026
• Last Updated: August 19, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1)