Thyroid NodulesTHYMAL 01NCT07488585
A Novel Ultrasound Probe for Thyroid Imaging and Machine Learning
A study testing Thyroid ultrasound in people with Thyroid Nodules and Thyroid Abnormalities, run by Sound Blade Medical Inc. at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Thyroid Nodules, Thyroid Abnormalities
- What is being tested?
- Thyroid ultrasound
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteCanada
- Study dates
- 1 Sep 2026to Sep 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Canada1 site, 1 recruiting
- Recruiting
Nova Scotia Health, Dartmouth
Dartmouth, Nova Scotia
Deborah Wright, RN, 902-225-6835, debbie.wright@nshealth.ca
About this study
Official title: A Novel Ultrasound Probe for Thyroid Imaging and Machine Learning: A Pilot Study
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
- Being tested
- Thyroid ultrasound
- Keywords
- Thyroid Nodule
- Medical subject headings
- Thyroid Nodule, Thyroid Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Thyroid ultrasoundDiagnostic test
Patients who are scheduled for a SOC surveillance Thyroid Nodule Ultrasound will undergo a second ultrasound using the Sound Blade Ultrasound.
| Study group | Role | What they receive |
|---|---|---|
| Thyroid Ultrasound | Experimental | Patients who are scheduled for a SOC surveillance Thyroid Nodule Ultrasound will undergo a second ultrasound using the Sound Blade Ultrasound. Receives: Diagnostic Test: Thyroid ultrasound |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Measured: 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.
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Mar 2026
- Study start1 Sep 2026 (estimated)
- Primary completion31 Dec 2026 (estimated)
- Study completionSep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Thyroid NodulesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sound Blade Medical Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Richard Bayls, MD, Principal investigator, Nova Scotia Health Authority
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07488585
- Sponsor's protocol ID
- THYMAL 01
- Acronym
- THYMAL 01
- Status last verified
- Aug 2026
- First submitted
- 27 Feb 2026
- Last updated
- 1 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Novel Ultrasound Probe for Thyroid Imaging and Machine Learning: A Pilot Study
- ClinicalTrials.gov ID
- NCT07488585
- Acronym / sponsor ID
- THYMAL 01 / THYMAL 01
- Conditions
- Thyroid Nodules, Thyroid Abnormalities
- Keywords
- Thyroid Nodule
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Sound Blade Medical Inc.Industry (pharma, biotech, devices)
- Study start
- 1 Sep 2026 (estimated)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- Sep 2027 (estimated)
- First posted
- 23 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Thyroid Ultrasound | Experimental | Diagnostic Test: Thyroid ultrasoundPatients who are scheduled for a SOC surveillance Thyroid Nodule Ultrasound will undergo a second ultrasound using the Sound Blade Ultrasound. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (5 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Thyroid ultrasoundPatients who are scheduled for a SOC surveillance Thyroid Nodule Ultrasound will undergo a second ultrasound using the Sound Blade Ultrasound. | Diagnostic test | Thyroid Ultrasound |
Primary outcome
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Sep 2026.
- Individual participant dataSharing planned: No
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Studies on Tumors of the Thyroid
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Richard Bayls, MD principal investigator
Nova Scotia Health Authority
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Thyroid ultrasound in people with Thyroid Nodules and Thyroid Abnormalities, run by Sound Blade Medical Inc. at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 1 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Deborah Wright, Project Manager, RN (902-225-6835, debbie.wright@nshealth.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The Ability to Visualization Thyroid Nodules and other key Anatomical Structures (time frame: Day 1). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Sep 2026.