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Sponsor study identifier
observational
1,500
1 country
1
Study Start
September 2022
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Primary Completion
December 2024
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Study Completion
December 2024
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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the transformation of imaging modes and the improvement of display capabilities, the imaging system of helical CT is no longer applicable.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
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December 2024
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
August 30, 2022
Actual (reported)September 2022
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September 9, 2022
Actual (reported)December 2024
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
December 2024
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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
Participants under the age of 18
Participants aged 18-30
Participants aged 31-40
Participants aged 41-50
Participants aged 51-60
Participants in the age groups undergo ultra-high-resolution computed tomography exam
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
* 50 healthy volunteers (100 ears) * otological patients 1450 cases (tinnitus\>634 ears, hearing loss\>634 ears, and vertigo\>181 ears)
Beijing Friendship Hospital, Capital Medical University
Beijing, Beijing Municipality, 100050, China
Zhenchang Wang, Prof.
Beijing Friendship Hospital
First Submitted
August 30, 2022
First Posted
September 9, 2022
Study Start
September 2022
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Primary Completion
Quantitative diagnostic standard for ear diseases based on U-HRCT image
size in milimeter of conductive and senserineural hearing pathways
2022.1-2024.12
Participants aged ≥61
Contact the study team to confirm eligibility.
December 2024
This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
December 2024
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
September 9, 2022
Record last verified: 2022-09
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Source: ClinicalTrials.gov.
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