AI Recognition of Important Structures in Otolaryngological Surgery

NCT ID: NCT06726551

Last Updated: 2024-12-10

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

1000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-01-01

Study Completion Date

2026-08-30

Brief Summary

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Developing a system for artificial intelligence to recognize anatomical landmarks in otolaryngological surgery, enabling real-time tracking of critical temporal bone structures during surgery.

Detailed Description

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Take the example of the Al recognition and prediction of the incus, external semicircular canal, facial nerve, and facial nerve recess. Within the defined surgical area, annotated data points are utilized to identify and segment the incus and the lateral semicircular canal based on their relative positions and angles concerning the posterior wall of the external auditory canal and the surrounding tissues. Detailed descriptions of the incus and lateral semicircular canal within the surgical area include: Incus: The incus is a small anvil-shaped bone located in the middle ear. It connects to the malleus laterally and the stapes medially. Identifying the incus accurately is crucial due to its proximity to the facial nerve and its involvement in the ossicular chain that transmits sound vibrations. Lateral Semicircular Canal: This is one of the three semicircular canals in the inner ear, oriented horizontally. It is involved in detecting rotational movements of the head. Proper identification is necessary to avoid damaging the canal, which could result in vertigo or balance issues. Input features include further contrast adjustment and localized magnification of images. The enhanced images are classified and localized using the trained model, and the consistency of multiple frames is utilized to determine the final positions of the facial nerve and the facial recess. Statistical analysis is conducted to predict the positions of the facial recess relative to the incus and lateral semicircular canal, providing reference information for surgeons. The system continuously monitors changes in the surgical area, offering dynamic feedback and optimizing the model's accuracy and robustness through incremental training.

Conditions

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Otolaryngological Diseases Requiring Mastoidectomy Middle Ear Surgery, Endolymphatic Sac Surgery, Cochlear Implant, Labyrinthectomy, Petrous Apex Lesions, Facial Nerve Surgery, and Lateral Skull Base Tumors

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

OTHER

Eligibility Criteria

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Inclusion Criteria

1. Performing otolaryngological surgeries such as cochlear implantation, endolymphatic sac decompression, semicircular canal plugging, and acoustic neuroma surgery using a microscope.
2. Microscopic exposure provides a comprehensive and clear view of the surgical area within the temporal bone.

Exclusion Criteria

1. No surgical video recording available.
2. Unclear visualization of the surgical area during microscopic otolaryngological procedures.
3. Incomplete visualization of the entire surgical process.
4. Patients who did not undergo high-resolution temporal bone CT at our hospital or Shenzhen Deep Bay Hospital.
Minimum Eligible Age

6 Months

Maximum Eligible Age

100 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Sun Yat-sen Memorial Hospital

Guangzhou, Guangdong, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Haidi Doctor Yang

Role: CONTACT

Phone: +86-131 7882 1663

Email: [email protected]

Jiaqi Doctor Pang

Role: CONTACT

Phone: +86-135 1272 2134

Email: [email protected]

Facility Contacts

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Liushan Ou

Role: primary

Other Identifiers

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SYSKY-2024-529-01

Identifier Type: -

Identifier Source: org_study_id