NCT07596355Not yet recruiting
AI-Assisted Endoscopy for Upper Aerodigestive Tract Lesions
Head&Neck Application of Novel Computer-assisted Endoscopy
Source: ClinicalTrials.gov · Last updated 19 May 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Study type
- Observational
- Enrollment
- 283 (estimated)
- First submitted
- 5 May 2026
- Start date
- 1 May 2026
- Primary completion date
- 31 Dec 2027
- Lead sponsor
- Istituto Italiano di Tecnologia
- Diseases
- Head and neck cancer
- NCT number
- NCT07596355
What you commit to
- Study type: Observational
- Planned participants: 283
- From 1 May 2026 to the primary completion date, 31 Dec 2027
- 3 sites in 3 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Patients with previous operations on the upper aero-digestive tract
- Patients with previous radiotherapy of the head and neck district
Other
- Submucosal lesion
- Poor compliance on endoscopic examination
- Unavailability of CADe/CADx or CASe data logging note
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (3)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| UZ Leuven Coordinator of this site? Confirm its status | Leuven | Belgium | Unknown status |
| Hospital Clinic de Barcelona Coordinator of this site? Confirm its status | Barcelona | Spain | Unknown status |
| IRCCS Ospedale Policlinico San Martino Coordinator of this site? Confirm its status | Genova | Italy | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.