Clinical Trial

AI-Assisted Ultrasound Review Before Thyroid Surgery

Completed
View on ClinicalTrials.gov →
Summary
This prospective, single-center, single-arm study evaluates a locked artificial intelligence (AI) system as a surgeon-led second-read tool before thyroid surgery. Eligible participants scheduled for thyroid surgery undergo standard ultrasonography followed by a standardized AI-assisted repeat examination. The AI system evaluates thyroid nodules only; cervical lymph nodes are assessed by clinicians. The study assesses participant-level supplementary pathological examinations and treatment-decision changes and evaluates nodule-level diagnostic performance against final surgical histopathology.
Protocol Amendment History 6 changes
critical Trial completed 2026-08-08
critical Primary endpoint(s) modified 2026-08-08
notable Enrollment increased: 300 -> 515 participants 2026-08-08
minor Trial arms changed: 2 -> 1 2026-08-08
notable Primary completion pushed: 2025-06-30 -> 2025-09-28 2026-08-08
minor Completion pushed: 2025-06-30 -> 2025-10-15 2026-08-08
Trial Details
NCT Number NCT06498674
Lead Sponsor Fujian Medical University
Conditions Thyroid Cancer, Thyroid Nodule
Enrollment 515 participants
Start Date 2024-09-01
Primary Completion 2025-09-28 (estimated)
Study Completion 2025-10-15 (estimated)
Updated on ClinicalTrials.gov 2026-08-07