ClinicalTrials.gg
RecruitingNCT07488585THYMAL 01Updated Sep 1, 2026

A Novel Ultrasound Probe for Thyroid Imaging and Machine Learning

An interventional study of Thyroid ultrasound in Thyroid Nodules and Thyroid Abnormalities, sponsored by Sound Blade Medical Inc.. Recruiting at 1 site in Canada. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-01.

Sponsored by Sound Blade Medical Inc. · Not applicable, Interventional, and Diagnostic

Phase
Not applicable
Study type
Interventional
Enrollment
30
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Thyroid Nodules
  • Thyroid Abnormalities

Keywords

  • Thyroid Nodule
03

In context

Thyroid Nodule

207 studies on the registry are indexed under Thyroid Nodule; 64 are open to participants now.

This study's planned enrollment of 30 is below the median of 75 across 121 interventional studies indexed under Thyroid Nodule.

Browse Thyroid Nodule studies →

Lead sponsor

This is the only study on the registry with Sound Blade Medical Inc. as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

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)
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Phase
Not applicable
Primary purpose
Diagnostic
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
30 participants (estimated)

Study arms

  • Experimental
    Thyroid Ultrasound

    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

  • Diagnostic testThyroid ultrasound

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

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: Day 1

  2. 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

    Time frame: Day 1

  3. 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.

    Time frame: Day 1

07

Study locations

1 of 1 sites recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 1, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07488585
Lead sponsor
Sound Blade Medical Inc.
Responsible party
Sponsor
First posted
Mar 23, 2026
Start date
Sep 1, 2026 (estimated)
Primary completion
Dec 31, 2026 (estimated)
Completion
Sep 2027 (estimated)
Last update
Sep 1, 2026

Study contacts

Deborah Wright, Project Manager, RN
Contact
debbie.wright@nshealth.ca
902-225-6835
Richard Balys, MD, MD
Contact
rbalys@gmail.com
902-223-8032
Richard Bayls, MD
principal investigator · Nova Scotia Health Authority

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Interested in this study?

Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.

Contact study team

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion