A Novel Ultrasound Probe for Thyroid Imaging and Machine Learning

NCT07488585 — Not applicable, Recruiting, 30 participants, Sound Blade Medical Inc.

ClinicalTrials Daily  ·  Areas  ·  Conditions  ·  Drugs  ·  Sponsors  ·  

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

RegistryNCT07488585, acronym THYMAL 01
StatusRecruiting
PhaseNot applicable
Study typeInterventional; na, single group, masking: none, diagnostic
Enrollment30 (Estimated)
SponsorSound Blade Medical Inc. (Industry)
ConditionsThyroid Nodules, Thyroid Abnormalities
InterventionsThyroid ultrasound (Diagnostic test)
Datesstart 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
Locations1 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

-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.

Expand all sections  ·  Collapse all

+Arms and interventions

ArmTypeInterventionsDescription
Thyroid UltrasoundExperimentalDiagnostic Test: Thyroid ultrasoundPatients who are scheduled for a SOC surveillance Thyroid Nodule Ultrasound will undergo a second ultrasound using the Sound Blade Ultrasound.
  • 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.

+Outcome measures

Primary outcomes

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

+Eligibility

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)

+Locations (1)

FacilityCityCountryStatus
Nova Scotia Health, DartmouthDartmouth, Nova ScotiaCanadaRecruiting

+Investigators