AI-Assisted Endoscopy for Upper Aerodigestive Tract Lesions

Starting soon

Conditions studied: 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, Vocal Fold Nodules

In brief

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.

Key facts

Study ID

NCT07596355

Run by

Istituto Italiano di Tecnologia

People needed

283

Starts

2026-05-01

Expected to finish

2028-02-01

Last updated by the study team

2026-05-19

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Age > 18 years
• Injury originating from the upper aero-digestive tract
• Recording of the video-endoscopic examination
• Patient known to undergo a biopsy of the lesion or clinical follow-up for lesion with known biopsy (e.g. laryngeal papillomatosis) or suffering from Reinke's edema (in this pathology, in fact, biopsy is not necessary since the diagnosis is clinical)
• Or patients undergoing transoral lesion excision

You may not qualify if…

• Submucosal lesion
• Patients with previous operations on the upper aero-digestive tract
• Patients with previous radiotherapy of the head and neck district
• Poor compliance on endoscopic examination
• Unavailability of CADe/CADx or CASe data logging note

Where it is running

• UZ Leuven — Leuven, Flemish Brabant, Belgium
• IRCCS Ospedale Policlinico San Martino — Genova, GE, Italy
• Hospital Clínic de Barcelona — Barcelona, Barcelona, Spain

Full record on ClinicalTrials.gov

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