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

NCT ID: NCT07326358

Last Updated: 2026-01-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

500 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-12-12

Study Completion Date

2027-03-31

Brief Summary

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

Detailed Description

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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.

Conditions

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Nasopharyngeal Neoplasms Laryngeal Disease

Study Design

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Observational Model Type

OTHER

Study Time Perspective

OTHER

Study Groups

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Model training and validation cohorts

A deep learning model is trained using the training dataset and validated with the internal validation set.

Diagnostic

Intervention Type OTHER

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

Prospective test cohort

Patients are prospectively enrolled, nasopharyngolaryngoscopy examination videos are collected, and the video data are processed to form a prospective test dataset, which is then used for testing.

Diagnostic

Intervention Type OTHER

The prospective dataset is used for the comparative testing of the model and physicians.

Interventions

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Diagnostic

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

Intervention Type OTHER

Diagnostic

The prospective dataset is used for the comparative testing of the model and physicians.

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ruijin Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Ruijin Hospital, Shanghai Jiao Tong University School of Medicine

Shanghai, , China

Site Status RECRUITING

Countries

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China

Central Contacts

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Bin Ye, MD PhD

Role: CONTACT

+8615216616895

Facility Contacts

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Bin Ye, MD PhD

Role: primary

+8615216616895

Other Identifiers

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2025-811

Identifier Type: -

Identifier Source: org_study_id

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