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 Type
INTERVENTIONAL
Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Enrollment
30
Patients who are scheduled for a SOC surveillance Thyroid Nodule Ultrasound will undergo a second ultrasound using the Sound Blade Ultrasound.
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.
Time frame: 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
Time frame: 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.
Time frame: Day 1
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