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NCT Number: NCT07326358

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

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

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Ruijin Hospital, Shanghai Jiao Tong University School of Medicine

Shanghai, China

Location status: Recruiting

Location contact

Bin Ye, MD PhD

CONTACT

[email protected]

+8615216616895

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Diagnostic

Other

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

Primary outcomes

  1. performance of lesion detection

    Time frame: Within 3 months after the completion of prospective data collection

    The area under the receiver operating characteristic curve (ROC-AUC) of the model for abnormal lesion detection

  2. performance of anatomic site recognition

    Time frame: Within 3 months after the completion of prospective data collection

    The average precision (AP) of the model for recognizing nasopharyngeal and laryngeal anatomic sites

Secondary outcomes

  1. Comparison of diagnostic performance between the model and physicians

    Time frame: Within 3 months after the completion of prospective data collection

    Differences in sensitivity, specificity, and overall accuracy between the AI model and endoscopists with different years of experience

Study contacts

Contact information is provided by the study sponsor or research team.

Bin Ye, MD PhD

CONTACT

[email protected]

+8615216616895

Sponsors and collaborators

Lead sponsor

Ruijin Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2026
Study completion
2027
First posted
Jan 8, 2026
Registry last updated
Jan 8, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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