Clinical trial · Interventional
A Novel Ultrasound Probe for Thyroid Imaging and Machine Learning
A Novel Ultrasound Probe for Thyroid Imaging and Machine Learning: A Pilot Study
NCT07488585CI-TRIAL-00124937THYMAL 01recruitingN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Thyroid Abnormalities | — | UNRESOLVED | — |
| Thyroid Nodules | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Thyroid ultrasound | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Thyroid Ultrasound
- description
- Patients who are scheduled for a SOC surveillance Thyroid Nodule Ultrasound will undergo a second ultrasound using the Sound Blade Ultrasound.
- interventionNames
- Diagnostic Test: Thyroid ultrasound
Primary outcomes (3)
- measure
- The Ability to Visualization Thyroid Nodules and other key Anatomical Structures
- timeFrame
- Day 1
- description
- 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.
- measure
- Evaluate the visibility/detection performance of a machine-learning model
- timeFrame
- Day 1
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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)
References
Publications (0)
Data not yet available
No reference posted for this study.