A Novel Ultrasound Probe for Thyroid Imaging and Machine Learning: A Pilot Study
| Registry | NCT07488585, acronym THYMAL 01 |
|---|---|
| Status | Recruiting |
| Phase | Not applicable |
| Study type | Interventional; na, single group, masking: none, diagnostic |
| Enrollment | 30 (Estimated) |
| Sponsor | Sound Blade Medical Inc. (Industry) |
| Conditions | Thyroid Nodules, Thyroid Abnormalities |
| Interventions | Thyroid ultrasound (Diagnostic test) |
| Dates | start 2026-09-01 (estimated), primary completion 2026-12-31 (estimated), completion 2027-09-01 (estimated), first posted 2026-03-23, last updated 2026-09-01 |
| Locations | 1 site in Canada |
Related Papers Related Patents Related Grants Related Experts
All trials for Thyroid Nodules All trials for Thyroid Abnormalities All trials of Thyroid ultrasound
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.
| Arm | Type | Interventions | Description |
|---|---|---|---|
| Thyroid Ultrasound | Experimental | Diagnostic Test: Thyroid ultrasound | Patients who are scheduled for a SOC surveillance Thyroid Nodule Ultrasound will undergo a second ultrasound using the Sound Blade Ultrasound. |
Sex: All, ages: 18 Years to any
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)
| Facility | City | Country | Status |
|---|---|---|---|
| Nova Scotia Health, Dartmouth | Dartmouth, Nova Scotia | Canada | Recruiting |