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NCT Number: NCT07726641

Artificial Intelligence-Assisted Training for Novice Physicians in Electronic Nasopharyngolaryngoscopy

This study aims to evaluate whether an artificial intelligence-assisted monitoring system can improve the training of novice physicians in electronic nasopharyngolaryngoscopy. The study will compare AI-assisted training with conventional training in terms of post-training examination performance.

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Key information

Conditions

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ruijin Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai

Shanghai, China

Location contact

Bin Ye, MD PhD

CONTACT

[email protected]

+8615216616895

About this study

Electronic nasopharyngolaryngoscopy is an important diagnostic procedure in otorhinolaryngology, but its examination quality is highly dependent on the operator's experience. Novice physicians may have difficulty in systematically visualizing key anatomical regions, maintaining a clear field of view, and completing a standardized examination.

Artificial intelligence-assisted monitoring systems may provide real-time feedback during endoscopic examination and help trainees improve anatomical site recognition and procedural completeness. This study is designed to evaluate the educational value of an AI-assisted monitoring system in the training of novice physicians performing electronic nasopharyngolaryngoscopy.

Novice physicians will be assigned to different training approaches, including an AI-assisted training method and a conventional training method. During the training phase, participants will receive supervised practice, with or without the support of the AI-assisted monitoring system, depending on group allocation.

Following the training period, participants will perform electronic nasopharyngolaryngoscopy under appropriate supervision. Their performance will be evaluated using recorded procedure data and expert assessment to compare outcomes between training approaches. Measures will be taken throughout the study to ensure patient safety under the guidance of experienced physicians.

Who can participate

Healthy volunteers accepted: Yes

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

Eligibility Criteria for Novice Physicians: Inclusion Criteria

  • Aged 18 years or older.
  • Otorhinolaryngology residents or standardized residency training physicians.
  • No prior independent experience in electronic nasopharyngolaryngoscopy.
  • Holding both a physician qualification certificate and a physician practice certificate registered at the study institution.
  • Willing to participate in the study and provide written informed consent. Exclusion Criteria
  • Previous participation in other endoscopy training studies.
  • Inability to complete the required continuous training period

Eligibility Criteria for Patient Participants: Inclusion Criteria

  • Aged 18 years or older.
  • Male or female.
  • Clinical need for electronic nasopharyngolaryngoscopy.
  • Able and willing to provide written informed consent. Exclusion Criteria
  • Pregnancy.
  • History of allergy to topical anesthetics such as tetracaine or lidocaine.
  • Language or communication barriers.
  • Anatomical abnormalities, such as laryngeal stenosis, or prior nasopharyngeal or laryngeal surgery.
  • Inability to tolerate the examination position.
  • Any condition judged by the investigator to make the participant unsuitable for the study.

Treatment and study plan

Artificial Intelligence-Assisted Monitoring System for Electronic Nasopharyngolaryngoscopy

Device

The AI-assisted monitoring system analyzes electronic nasopharyngolaryngoscopy video in real time and provides prompts regarding anatomical sites that have been examined. Examined anatomical sites are displayed on the screen, and the system provides information such as examination time and number of anatomical sites covered. The system is used as an adjunctive training tool and does not replace the clinical judgment of supervising physicians.

Primary outcomes

  1. Post-training procedural performance score

    Time frame: During each post-training assessment procedure.

    Each post-training procedure will be video recorded and assessed by blinded expert raters using Flexible Pharyngo-Laryngoscopy Assessment Tool (FLEXPAT). The scale includes 9 mandatory items, each scored from 1 to 5, with a total score ranging from 9 to 45 points. A higher score indicates better procedural performance.

Secondary outcomes

  1. Anatomical Site Coverage Rate

    Time frame: During each post-training assessment procedure.

  2. Examination Time

    Time frame: During each post-training assessment procedure.

  3. Image Quality Score

    Time frame: During each post-training assessment procedure.

    Image quality will be evaluated by professional raters across two dimensions based on the images captured during the procedure: preservation of anatomical sites and mucosal clarity. Each dimension is scored out of a maximum of 5 points, with a total combined score of 10 points.

  4. Patient Comfort

    Time frame: Immediately after or during each post-training assessment procedure.

    Patient comfort will be evaluated based on clinical observation of examination-related discomfort, such as gag reflex, and categorized as good comfort, poor comfort, or very poor comfort.

  5. Trainee Satisfaction with the AI System

    Time frame: Within 2 weeks after completion of the training phase

    Trainees in the AI-assisted training group shall complete a satisfaction questionnaire with a Likert-type scale to assess their experience using the AI-assisted monitoring system. The questionnaire consists of 10 survey items with five rating levels ranging from strongly disagree (1 point) to strongly agree (5 points).

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

Application of an Artificial Intelligence-Assisted Monitoring System for Electronic Nasopharyngolaryngoscopy in the Training of Novice Physicians: A Prospective, Single-Center, Randomized Controlled Study

Important dates

Study start
2026
Primary completion
2026
Study completion
2027
First posted
Jul 24, 2026
Registry last updated
Jul 24, 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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