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Research on The Application of 3D Microscopic Imaging Digital Observation System in Otological Microsurgery

Research on The Application of 3D Microscopic Imaging Digital Observation System in Otological Microsurgery

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2300078548
Enrollment
Unknown
Registered
2023-12-12
Start date
2023-12-15
Completion date
Unknown
Last updated
2023-12-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

otitis media,sensorineural hearing loss

Interventions

Traditional microscope surgery group:Otologic surgery through traditional microscope
Ultra High Definition 3D External Vision System surgery group:Otologic Surgery by 3D External Vision System
CT scan of the temporal bone was normal:NA
CT scan of the temporal bone was structural inflammation:NA
CT scan of the temporal bone was otitis media:NA
CT scan of the temporal bone was tumor:NA
Cochlear implantation microscopic 3D-4K stereoscopic surgical videos:NA

Sponsors

Chinese PLA General Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
No minimum to 80 Years

Inclusion criteria

Inclusion criteria: Inclusion criteria for instrument functional validation trial subjects: Patients who are candidates for cochlear implantation surgery due to unilateral/bilateral severe/profound hearing loss, and patients who are candidates for tympanoplasty or mastoidectomy surgery due to otitis media, cholesteatoma, or other middle ear diseases. Inclusion criteria for imaging data: Patients who have undergone temporal bone CT examination at our hospital, with complete imaging and diagnostic reports. Inclusion criteria for surgical videos: Surgical videos recorded in 3D format throughout the procedure.

Exclusion criteria

Exclusion criteria: Exclusion criteria for instrument functional validation trial subjects: Patients who clearly refuse to participate in the project after receiving education; Patients who have undergone previous similar ear surgeries or radiation therapy; Patients whose preoperative examination indicates diseases such as petrous apex cholesteatoma or temporal bone tumors; Patients who are planned for ear surgery under endoscopy according to their condition; Patients with other diseases who are unable to tolerate surgery for hearing loss. Exclusion criteria for imaging data: Imaging clearly identified as postoperative follow-up images; Selection of the first examination images for multiple examinations of the same patient; Images that are blurred or cannot be clearly displayed due to other reasons; Imaging examinations performed at other hospitals; Non-axial scans, non-temporal bone scans, and three-dimensional reconstruction scans; Image slice thickness greater than 1.3mm. Exclusion criteria for surgical videos: Surgical videos recorded in 2D format; Microscope, endoscope combined surgical videos; Endoscopic surgical videos recorded in 2D format.

Design outcomes

Primary

MeasureTime frame
Surgery time;Software Measured Values;receiver operating characteristic curve;Accuracy;Area under roc Curve, AUC;

Secondary

MeasureTime frame
Pre-screen display delay;Pre-screen display color and resolution;Intraoperative Bleeding;Postoperative Complications;

Countries

China

Contacts

Public ContactPU DAI

Chinese PLA General Hospital

daipu301@vip.sina.com+86 139 1021 3511

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026