AI for Onsite Cytology Evaluation in Endoscopic Ultrasound

Part of paid clinical trials in Orlando, Florida.

Sponsor
Orlando Health, Inc.
Study ID
NCT07228689
Status
Recruiting
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Conditions

  • Gastrointestinal Neoplasm
  • Mass Lesion

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • EUS-guided fine needle biopsy — DIAGNOSTIC_TEST
    EUS-guided fine needle biopsy of solid mass lesions in the gastrointestinal tract

Study Details

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.

Key Dates

Start date
Nov 12, 2025
Status verified
Nov 2025
Primary completion
Dec 31, 2026
Completion
Oct 31, 2027

Study Design

Enrollment
200 participants (estimated)

Arms

  • Arm: Interpretation of cytology specimen by cytopathologist onsite
    The interpretation of the cytology specimens will be made onsite by the cytopathologist
  • Arm: Interpretation of cytology specimen by artificial intelligence
    The interpretation of the cytology specimens will be made onsite by the AI program

Primary Outcome Measure

Diagnostic accuracy at rapid onsite evaluation [ Time Frame: 1 day ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Orlando Health Digestive Health InstituteOrlandoFlorida32806
Barbara J Broome
[email protected]
321-842-6416

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By research site
Orlando Health Digestive Health Institute· Orlando, FL

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