Brief Summary

Tinnitus, hearing loss and vertigo are the three major diseases of otology, affecting hundreds of millions of people in our country, and are major health problems. Ear structures and lesions are deeply embedded in the bone, and CT is the preferred examination technique. The key structures of the ear are small and the lesions are hidden. Spiral CT is "not visible" and "undiagnosed" due to insufficient spatial resolution. The ultra-high-resolution CT independently developed by our team has a spatial resolution of 50 μm, which is 6 times higher than that of high-end spiral CT, and solves the problem of "not showing" ear diseases. However, with the transformation of imaging modes and the improvement of display capabilities, the imaging system of helical CT is no longer applicable. It is urgent to carry out systematic research to create matching imaging plans, imaging anatomy standards and disease assessment standards to solve the problem of "undiagnosed". problem. This project plans to build an adult and pediatric imaging solution based on ultra-high-resolution CT to optimize image quality and radiation dose; comprehensively evaluate conduction, sensory, and surgical-related fine structures of the ear, and establish a new 0.1mm-scale image anatomy atlas; A prospective study conducted by the center analyzes the hidden pathological changes of tinnitus, deafness and vertigo, evaluates the diagnostic efficacy of ultra-high-resolution CT for the above diseases, and establishes new diagnostic criteria for lesion detection, symptom correlation, and efficacy evaluation. This project will bring new changes to the practice of otology clinical diagnosis and treatment

Trial Health

At Risk

Trial Health Score

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

Trial has exceeded expected completion date

Enrollment

1,500

participants targeted

Target at P75+ for all trials

Timeline

Completed

Started Sep 2022

Typical duration for all trials

Geographic Reach

1 country

1 active site

Status

unknown

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

2.3 years study duration

First Submitted

Initial submission to the registry

August 30, 2022

Completed

2 days until next milestone

Study Start

First participant enrolled

September 1, 2022

Completed

8 days until next milestone

First Posted

Study publicly available on registry

September 9, 2022

Completed

2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2024

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2024

Completed

Last Updated

September 9, 2022

Status Verified

September 1, 2022

Enrollment Period

2.3 years

First QC Date

August 30, 2022

Last Update Submit

September 5, 2022

Conditions

Hearing Loss Tinnitus Vertigo

Keywords

OtologyMedical imagingTomography, X-rayDiagnosisResolution

Outcome Measures

Primary Outcomes (5)

Subjective and objective evaluation methods for CT image quality
Image quality (Likert score) and image noise will be combined to report the optimal image quality-noise combination
2022.1-2024.12
Radiological anatomy of normal ears based on ultra-high resolution CT
diameters in milimeter
2022.1-2024.12
Radiological anatomy of normal ears based on ultra-high resolution CT
angle in degree
2022.1-2024.12
Quantitative diagnostic standard for ear diseases based on U-HRCT image
shape and position of conductive and senserineural hearing pathways
2022.1-2024.12
Quantitative diagnostic standard for ear diseases based on U-HRCT image
size in milimeter of conductive and senserineural hearing pathways
2022.1-2024.12