Not Yet RecruitingNot Applicable

AI-Assisted Endoscopy for Upper Aerodigestive Tract Lesions

Belgium, Italy, Spain283 participantsStarted 2026-05

Plain-language summary

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.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * 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 Exclusion Criteria: * 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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Negative Predictive Value of the CADx Algorithm for Malignant or Premalignant Upper Aerodigestive Tract Lesions

Timeframe: From index outpatient UADT video-endoscopy until definitive histopathology result is available, assessed up to 60 days after endoscopy.

Sensitivity of the CADe Algorithm for Localization of Upper Aerodigestive Tract Lesions

Timeframe: At index outpatient UADT video-endoscopy, with blinded post-processing assessment performed up to 30 days after endoscopy.

Median Intersection Over Union Between CASe Segmentation and Surgeon-Drawn Lesion Margins

Timeframe: At intraoperative pre-resection endoscopy, with assessment performed after image annotation up to 30 days after surgery.

Median Dice Similarity Coefficient Between CASe Segmentation and Surgeon-Drawn Lesion Margins

Timeframe: At intraoperative pre-resection endoscopy, with assessment performed after image annotation up to 30 days after surgery.

Trial details

NCT IDNCT07596355

SponsorIstituto Italiano di Tecnologia

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2027-12

Contact for this trial

Leonardo De Mattos, PhD

+39 010 2898 270 leonardo.demattos@iit.it

View on ClinicalTrials.gov More Upper Aerodigestive Tract Neoplasms trials