AI-Assisted Endoscopy for Upper Aerodigestive Tract Lesions

This is a prospective observational clinical study designed to evaluate the performance of artificial intelligence (AI) algorithms applied to upper aerodigestive tract (UADT) video-endoscopy. The study assesses three main tasks: lesion detection (localization), classification (benign vs malignant), and segmentation of tumor margins. AI algorithms will be applied to endoscopic video data acquired during routine clinical practice without influencing clinical decision-making. The system will process images in real time and store data for subsequent analysis. AI outputs will be compared with physician assessment and reference standard histopathology to evaluate diagnostic performance.

NCT Number	NCT07596355
Lead Sponsor	Istituto Italiano di Tecnologia Collaborators: Hospital Clinic of Barcelona, CRO "Centro Clinical Trials" IRCCS Ospedale Policlinico San Martino, Universitaire Ziekenhuizen KU Leuven, Università degli Studi 'G. d'Annunzio' Chieti e Pescara, Universita degli Studi di Genova, Scuola Superiore di Studi Universitari e di Perfezionamento Sant'Anna
Conditions	Upper Aerodigestive Tract Neoplasms, Upper AerodigestiveTract Cancer, Upper Aero-digestive Tract (UADT) Neoplasm, Squamous Cell Carcinoma, Leukoplakia, Head and Neck Cancer (H&N), Vocal Cord Disease, Vocal Fold Polyp +1 more
Enrollment	283 participants
Start Date	2026-05
Primary Completion	2027-12 (estimated)
Study Completion	2028-02 (estimated)
Updated on ClinicalTrials.gov	2026-05-19