Recruiting

Sound Blade Imaging

Sponsor:

Sound Blade Medical Inc.

Code:

NCT07488585

Conditions

Thyroid Nodules

Thyroid Abnormalities

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Thyroid ultrasound

Study Details

Brief 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.

Conditions

Thyroid Nodules

Thyroid Abnormalities

Study ID

NCT07488585

Start date

Sep 1, 2026

Status verified date

Aug, 2026

Completion date

Sep, 2027

Anticipated

Primary completion date

Dec 31, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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)

Study Design

Enrollment

30 participants

Anticipated

Intervention Model

Single group

Primary purpose

Diagnostic

Interventions and Outcome Measures

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.

Interventions

Thyroid ultrasound

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

Primary outcome measure

  • The Ability to Visualization Thyroid Nodules and other key Anatomical Structures [ Time Frame: Day 1 ]
  • Evaluate the visibility/detection performance of a machine-learning model [ Time Frame: Day 1 ]
  • Evaluate the segmentation performance of a machine-learning model [ Time Frame: Day 1 ]

Central Contacts and Locations

Central contacts

Deborah Wright, Project Manager, RN

902-225-6835debbie.wright@nshealth.ca

Richard Balys, MD, MD

902-223-8032rbalys@gmail.com

Locations

Nova Scotia Health, Dartmouth

Recruiting

Dartmouth, Nova Scotia, Canada

Contacts

Deborah Wright, RN

902-225-6835debbie.wright@nshealth.ca

More Information

Sponsor

Sound Blade Medical Inc.

Last update posted

Sep 1, 2026

Last verified

Aug, 2026

Keywords

  • Thyroid Nodule

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Sound Blade Medical Inc. on 2026-09-01.