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AI-Assisted Endoscopy for Upper Aerodigestive Tract Lesions

NCT07596355 · Status: NOT_YET_RECRUITING · Type: OBSERVATIONAL · Enrollment: 283

Last updated 2026-05-19

No results posted yet for this study

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.

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
  • Vocal Fold Nodules

Sponsors & Collaborators

  • Hospital Clinic of Barcelona

    collaborator OTHER

  • CRO "Centro Clinical Trials" IRCCS Ospedale Policlinico San Martino

    collaborator UNKNOWN

  • Universitaire Ziekenhuizen KU Leuven

    collaborator OTHER

  • Università degli Studi 'G. d'Annunzio' Chieti e Pescara

    collaborator OTHER

  • Universita degli Studi di Genova

    collaborator OTHER

  • Scuola Superiore Sant'Anna di Pisa

    collaborator OTHER

  • Istituto Italiano di Tecnologia

    lead OTHER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-05-31
Primary Completion
2027-12-31
Completion
2028-02-29

Countries

  • Belgium
  • Italy
  • Spain

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07596355 on ClinicalTrials.gov