NCT07726641

Brief Summary

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.

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
138

participants targeted

Target at P50-P75 for not_applicable

Timeline
7mo left

Started Jul 2026

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress13%
Jul 2026Feb 2027

First Submitted

Initial submission to the registry

July 1, 2026

Completed
Same day until next milestone

Study Start

First participant enrolled

July 1, 2026

Completed
23 days until next milestone

First Posted

Study publicly available on registry

July 24, 2026

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2026

Expected
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 28, 2027

Last Updated

July 24, 2026

Status Verified

June 1, 2026

Enrollment Period

6 months

First QC Date

July 1, 2026

Last Update Submit

July 21, 2026

Conditions

Outcome Measures

Primary Outcomes (1)

  • Post-training procedural performance score

    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.

    During each post-training assessment procedure.

Secondary Outcomes (5)

  • Anatomical Site Coverage Rate

    During each post-training assessment procedure.

  • Examination Time

    During each post-training assessment procedure.

  • Image Quality Score

    During each post-training assessment procedure.

  • Patient Comfort

    Immediately after or during each post-training assessment procedure.

  • Trainee Satisfaction with the AI System

    Within 2 weeks after completion of the training phase

Study Arms (2)

AI-Assisted Training Group

EXPERIMENTAL

Novice physicians in this group will receive additional assistance from an AI-assisted monitoring system during electronic nasopharyngolaryngoscopy training. The AI system provides real-time monitoring and visual prompts for anatomical site coverage during the examination.

Device: Artificial Intelligence-Assisted Monitoring System for Electronic Nasopharyngolaryngoscopy

Conventional Training Group

NO INTERVENTION

Novice physicians in this group will receive conventional theoretical and practical training in electronic nasopharyngolaryngoscopy without real-time AI assistance during training.

Interventions

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.

AI-Assisted Training Group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • Previous participation in other endoscopy training studies.
  • Inability to complete the required continuous training period
  • Aged 18 years or older.
  • Male or female.
  • Clinical need for electronic nasopharyngolaryngoscopy.
  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Shanghai, China

Location

Central Study Contacts

Bin Ye, MD PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 1, 2026

First Posted

July 24, 2026

Study Start

July 1, 2026

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

February 28, 2027

Last Updated

July 24, 2026

Record last verified: 2026-06

Data Sharing

IPD Sharing
Will not share

Individual participant data will not be shared publicly. The study involves clinical and endoscopic video data collected from patients, which may contain sensitive medical information. Due to privacy protection, ethical requirements, and institutional data governance policies, de-identified individual participant data will not be made available outside the research team.

Locations