A Novel Ultrasound Probe for Thyroid Imaging and Machine Learning

NCT07488585 | Recruiting

• 1 other identifier: THYMAL 01
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

The objective of the THYMAL 01 pilot study is to evaluate the Sound Blade Imaging System in subjects with benign thyroid nodules undergoing standard-of-care ultrasound imaging.

Conditions

Thyroid Nodules; Thyroid Abnormalities

Keywords

Thyroid Nodule

Outcome Measures

Primary Outcomes (3)

• The Ability to Visualization Thyroid Nodules and other key Anatomical Structures

  The primary endpoint is to evaluate the ability to visualize thyroid nodules and other key anatomical structures with the investigational device compared to the SOC US imaging device.

  Day 1

• Evaluate the visibility/detection performance of a machine-learning model

  A machine-learning model will be created to identify and segment thyroid nodules and key anatomical neck structures. The first outcome will evaluate performance of visibility and detection using standard classification measures

  Day 1

• Evaluate the segmentation performance of a machine-learning model

  A machine-learning model will be created to identify and segment thyroid nodules and key anatomical neck structures. The second outcome will evaluate performance on delineable cases.

  Day 1

Study Arms (1)

Thyroid Ultrasound

EXPERIMENTAL

Patients who are scheduled for a SOC surveillance Thyroid Nodule Ultrasound will undergo a second ultrasound using the Sound Blade Ultrasound.

Diagnostic Test: Thyroid ultrasound

Interventions

Thyroid ultrasound DIAGNOSTIC_TEST

Patients who are scheduled for a SOC surveillance Thyroid Nodule Ultrasound will undergo a second ultrasound using the Sound Blade Ultrasound.

Thyroid Ultrasound

Eligibility Criteria

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

You may qualify if:

• Participants must be ≥ 18 years of age
• Able and willing to sign informed consent
• Known thyroid nodule demonstrated on a prior thyroid US and is undergoing active surveillance of the nodule with serial USs

You may not qualify if:

• Unable to lay flat for 15 minutes
• Active neck wounds, dressings, or skin conditions that would interfere with neck US (e.g., preclude transducer placement)
• Cervical spine or back disease that would prevent neck extension and would hinder the ability to obtain accurate thyroid US images
• Previous thyroid surgeries, radiation of face and neck
• Known inflammatory thyroid diseases or thyroiditis (e.g., Graves, Hashimoto)

Sponsors & Collaborators

• Sound Blade Medical Inc.: lead

Study Sites (1)

Nova Scotia Health, Dartmouth

Dartmouth, Nova Scotia, Canada

RECRUITING

MeSH Terms

Conditions

Thyroid Nodule; Thyroid Diseases

Condition Hierarchy (Ancestors)

Thyroid Neoplasms; Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Head and Neck Neoplasms; Endocrine System Diseases

Study Officials

• Richard Bayls, MD

  Nova Scotia Health Authority

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Deborah Wright, Project Manager, RN

CONTACT

902-225-6835; debbie.wright@nshealth.ca

Richard Balys, MD, MD

CONTACT

902-223-8032; rbalys@gmail.com

Study Design

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

Study Record Dates

• First Submitted: February 27, 2026
• First Posted: March 23, 2026
• Study Start: September 1, 2026
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): September 1, 2027
• Last Updated: September 1, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)