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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Thyroid Ultrasound | Experimental | Patients who are scheduled for a SOC surveillance Thyroid Nodule Ultrasound will undergo a second ultrasound using the Sound Blade Ultrasound. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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 | 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. | Day 1 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Deborah Wright, Project Manager, RN | Contact | 902-225-6835 | debbie.wright@nshealth.ca | |
| Richard Balys, MD, MD | Contact | 902-223-8032 | rbalys@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Richard Bayls, MD | Nova Scotia Health Authority | Principal Investigator |
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This is an internal feasibility study at this point.
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| ID | Term |
|---|---|
| D016606 | Thyroid Nodule |
| D013959 | Thyroid Diseases |
| ID | Term |
|---|---|
| D013964 | Thyroid Neoplasms |
| D004701 | Endocrine Gland Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| D006258 |
| Head and Neck Neoplasms |
| D004700 | Endocrine System Diseases |