A Novel Ultrasound Probe for Thyroid Imaging and Machine Learning

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.

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Key information

Conditions

Thyroid Nodules Endocrine Gland Neoplasms Endocrine System Diseases Head and Neck Neoplasms Neoplasms Neoplasms by Site Thyroid Abnormalities Thyroid Diseases Thyroid Neoplasms Thyroid Nodule

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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)

Treatment and study plan

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.

Primary outcomes

The Ability to Visualization Thyroid Nodules and other key Anatomical Structures

Time frame: Day 1

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

Time frame: Day 1

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
Evaluate the segmentation performance of a machine-learning model

Time frame: Day 1

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.

Study contacts

Contact information is provided by the study sponsor or research team.

Deborah Wright, Project Manager, RN

CONTACT

[email protected]

902-225-6835

Richard Balys, MD, MD

CONTACT

[email protected]

902-223-8032

Sponsors and collaborators

Lead sponsor

Sound Blade Medical Inc.

Industry

Registry information

Official study title

A Novel Ultrasound Probe for Thyroid Imaging and Machine Learning: A Pilot Study

Acronym: THYMAL 01

Important dates

Study start: 2026
Primary completion: 2026
Study completion: 2027
First posted: Mar 23, 2026
Registry last updated: Apr 7, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Enrolling by Invitation