Skip to content

AI System for Anatomic Recognition & Lesion Detection in Nasopharyngolaryngoscopy: A Prospective Study

Development and Validation of an Artificial Intelligence System for Anatomic Site Recognition and Lesion Detection Based on Electronic Nasopharyngolaryngoscopic Images: A Prospective Multicenter Study

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07326358
Enrollment
500
Registered
2026-01-08
Start date
2025-12-12
Completion date
2027-03-31
Last updated
2026-01-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Laryngeal Disease, Nasopharyngeal Neoplasms

Brief summary

An artificial intelligence-assisted system is trained and validated by collecting nasopharyngolaryngoscopy images from patients.

Detailed description

To address the clinical pain points of traditional nasopharyngolaryngoscopy, such as incomplete visualization, inaccurate identification, and unclear imaging, this study will retrospectively collect nasopharyngolaryngoscopy images and baseline information (including gender and age) of patients who underwent nasopharyngolaryngoscopy at participating centers for model training and validation. Deep learning algorithms will be applied to construct the model. The final clinical performance evaluation of the model will be conducted using an independent, prospectively collected test cohort.

Interventions

OTHERDiagnostic

The deep learning model is trained using the training dataset and tested with the internal validation set.

Sponsors

Ruijin Hospital
Lead SponsorOTHER

Study design

Observational model
OTHER
Time perspective
OTHER

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Age ≥ 18 years; * Underwent standard electronic nasopharyngolaryngoscopy; * Patients who underwent biopsy sampling have a clear pathological diagnosis; * Signed a written informed consent form.

Exclusion criteria

* Image quality is substandard with severe motion artifacts; * Lesion images are unclear and incomplete.

Design outcomes

Primary

MeasureTime frameDescription
performance of lesion detectionWithin 3 months after the completion of prospective data collectionThe area under the receiver operating characteristic curve (ROC-AUC) of the model for abnormal lesion detection
performance of anatomic site recognitionWithin 3 months after the completion of prospective data collectionThe average precision (AP) of the model for recognizing nasopharyngeal and laryngeal anatomic sites

Secondary

MeasureTime frameDescription
Comparison of diagnostic performance between the model and physiciansWithin 3 months after the completion of prospective data collectionDifferences in sensitivity, specificity, and overall accuracy between the AI model and endoscopists with different years of experience

Countries

China

Contacts

Primary ContactBin Ye, MD PhD
aydyebin@126.com+8615216616895

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026