Actively Recruiting
Development and Validation of an Artificial Intelligence System for Anatomic Site Recognition and Lesion Detection Based on Electronic Nasopharyngolaryngoscopic Images: A Prospective Multicenter Study
Led by Ruijin Hospital · Updated on 2026-01-08
500
Participants Needed
1
Research Sites
12 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating an artificial intelligence-assisted system designed to improve the detection of anatomical sites and lesions during nasopharyngolaryngoscopy, a procedure used to examine the nasopharynx and larynx. The study aims to address challenges of traditional procedures such as incomplete visualization and unclear imaging by training and validating a deep learning model using collected images and patient data from multiple centers. The study involves collecting electronic nasopharyngolaryngoscopy images and baseline patient information, including gender and age, to train and validate the AI model. Initially, the model is trained using a retrospective dataset and internally validated. Subsequently, the clinical performance of the model is assessed prospectively by enrolling patients, collecting new nasopharyngolaryngoscopy videos, and testing the model against this independent dataset. Participants will undergo standard nasopharyngolaryngoscopy exams, with their images and videos collected for analysis. Researchers will compare the model’s lesion detection and anatomic site recognition performance to that of physicians. Outcome measures are evaluated within three months after completing data collection. The study runs from December 2025 to March 2027 and includes assessments of diagnostic accuracy and comparative performance between the AI system and medical professionals.
CONDITIONS
Brief Title
AI System for Anatomic Recognition & Lesion Detection in Nasopharyngolaryngoscopy: A Prospective Study
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 2 18 years
- Underwent standard electronic nasopharyngolaryngoscopy
- Patients who underwent biopsy sampling have a clear pathological diagnosis
- Signed a written informed consent form
You will not qualify if you...
- Image quality is substandard with severe motion artifacts
- Lesion images are unclear and incomplete
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Prospective data collection period
Participants undergo nasopharyngolaryngoscopy examinations where videos are collected to evaluate the anatomic site recognition and lesion detection capabilities of the AI system.
1 visit (in-person) for nasopharyngolaryngoscopy
Duration - Up to 3 months after prospective data collection completion
Collected data are used to compare the diagnostic performance of the AI model with physicians over the study period.
No additional visits; data analysis only
Trial Site Locations
Total: 1 location
1
Ruijin Hospital, Shanghai Jiao Tong University School of Medicine
Shanghai, China
Actively Recruiting
Research Team
B
Bin Ye, MD PhD
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
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