LaryngoscopyNCT07726641
Artificial Intelligence-Assisted Training for Novice Physicians in Electronic Nasopharyngolaryngoscopy
A study testing Artificial Intelligence-Assisted Monitoring System for Electronic Nasopharyngolaryngoscopy in people with Laryngoscopy and Training, run by Ruijin Hospital at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Laryngoscopy, Training
- What is being tested?
- Artificial Intelligence-Assisted Monitoring System for Electronic Nasopharyngolaryngoscopy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 138 participants
- Where
- 1 siteChina
- Study dates
- 1 Jul 2026to 28 Feb 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Ruijin Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai
Shanghai
Bin Ye, MD PhD, +8615216616895, aydyebin@126.com
About this study
Official 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
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.
Read the detailed description
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.
- Conditions
- Laryngoscopy, Training
- Being tested
- Artificial Intelligence-Assisted Monitoring System for Electronic Nasopharyngolaryngoscopy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Artificial Intelligence-Assisted Monitoring System for Electronic NasopharyngolaryngoscopyDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: During each post-training assessment procedure.
Secondary outcomes (5)
Anatomical Site Coverage Rate
Measured: During each post-training assessment procedure.
Examination Time
Measured: During each post-training assessment procedure.
Image Quality Score
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.
Measured: During each post-training assessment procedure.
Patient Comfort
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.
Measured: Immediately after or during each post-training assessment procedure.
Trainee Satisfaction with the AI System
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).
Measured: Within 2 weeks after completion of the training phase
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2026
- Study start1 Jul 2026 (estimated)
- Primary completion31 Dec 2026 (estimated)
- Study completion28 Feb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for LaryngoscopyStudies of the same condition, open and under way.
- More trials run by Ruijin HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 138 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ruijin Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07726641
- Sponsor's protocol ID
- 2025-802a
- Status last verified
- Jun 2026
- First submitted
- 1 Jul 2026
- Last updated
- 24 Jul 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT07726641
- Acronym / sponsor ID
- 2025-802a
- Conditions
- Laryngoscopy, Training
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 138 participants (estimated)
- Lead sponsor
- Ruijin HospitalUniversity, hospital or other
- Study start
- 1 Jul 2026 (estimated)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 28 Feb 2027 (estimated)
- First posted
- 24 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| AI-Assisted Training Group | Experimental | Device: Artificial Intelligence-Assisted Monitoring System for Electronic NasopharyngolaryngoscopyNovice 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. |
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Artificial Intelligence-Assisted Monitoring System for Electronic NasopharyngolaryngoscopyThe 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. | Device | AI-Assisted Training Group |
Primary outcome
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.
5 secondary outcomes
Anatomical Site Coverage Rate
Time frame: During each post-training assessment procedure.
Examination Time
Time frame: During each post-training assessment procedure.
Image Quality Score
Time frame: During each post-training assessment procedure.
Patient Comfort
Time frame: Immediately after or during each post-training assessment procedure.
Trainee Satisfaction with the AI System
Time frame: Within 2 weeks after completion of the training phase
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jul 2026.
- Individual participant dataSharing planned: No. 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.
Related trials for Laryngoscopy
Not yet recruitingObservational study
LeHeR Maneuver vs Sniffing Position During Video Laryngoscopy in Predicted Difficult Airway
Difficult Airway, Difficult Intubation
Not yet recruitingObservational study
Sniffing Position vs Left Head Rotation (LeHeR) Maneuver for Glottic View During Direct Laryngoscopy
Difficult Intubation, Laryngoscopy
Recruiting
Hyperangulated vs. Macintosh Style Blades for Intubation in Obstetric Patients
Obstetric, Cesarean Birth
Active, not recruiting
OR Video-Laryngoscope Evaluations
Video Laryngoscopy, Quality Improvement
RecruitingPhase 4
Remifentanil Versus Rocuronium for Optimizing Video Laryngoscopy-assisted Tracheal Intubation
Tracheal Intubation, Video Laryngoscopy
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Artificial Intelligence-Assisted Monitoring System for Electronic Nasopharyngolaryngoscopy in people with Laryngoscopy and Training, run by Ruijin Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 24 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Bin Ye, MD PhD (+8615216616895, aydyebin@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Post-training procedural performance score (time frame: During each post-training assessment procedure.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jul 2026; AzTrials last refreshed its copy on 6 Nov 2026.