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AI for Onsite Cytology Evaluation in Endoscopic Ultrasound

StatusActive, Not Recruiting
PhaseNot specified
Started
View on ClinicalTrials.gov ↗

Record History

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  1. Notable Primary endpoint(s) modified
    • Secondary endpoint revised
    v3
  2. Minor Trial status: Recruiting to Active, Not Recruitingv2 Show 5 more changesShow less
    • Enrollment target: estimated 200 to confirmed 136
    • Primary completion date changed from estimate of Dec 2026 to Apr 6, 2026
    • Study completion date: Oct 2027 to Dec 2026
    • Start date: Nov 12, 2025 to Nov 17, 2025
    • Site details revised
  3. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
The aim of this study is to determine if the widely available artificial intelligence platform ChatGPT can accurately identify the abnormalities present on cytology specimens obtained at EUS-FNB of solid mass lesions in the gastrointestinal tract, in comparison with interpretation by cytopathologists as the gold standard.
Trial Details
NCT Number NCT07228689
Lead Sponsor Orlando Health, Inc.
Conditions
(from sponsor)
Gastrointestinal Neoplasm, Mass Lesion
Related terms Gastrointestinal Neoplasms
Enrollment 136 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov