Establishment and Application of a New Imaging System for Otology Based on Ultra-high Resolution CT

September 5, 2022 updated by: Wang, Zhenchang, Beijing Friendship Hospital
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the transformation of imaging modes and the improvement of display capabilities, the imaging system of helical CT is no longer applicable.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

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
1500

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China, 100050
        • Recruiting
        • Beijing Friendship hospital, Capital Medical University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

  • 50 healthy volunteers (100 ears)
  • otological patients 1450 cases (tinnitus>634 ears, hearing loss>634 ears, and vertigo>181 ears)

Description

  1. For healthy volunteers

    Inclusion Criteria:

    • Meet the ethical requirements of U-HRCT examination
    • Can cooperate to complete U-HRCT examination
    • There is no relevant medical history in the side ear scanned

    Exclusion Criteria:

    • Clinical symptoms related to middle and inner ear lesions, such as conduction deafness, sensorineural hearing loss, mixed deafness, vertigo, etc.
    • Congenital inner ear malformation
    • Diseases causing bone changes around the middle and inner ear, such as otitis media, tumors , otosclerosis, fibrous dysplasia, etc.
    • history of previous ear surgery and trauma
    • CT image artifacts or incomplete scan coverage
    • incomplete clinical data
  2. For patients with otological diseases

Inclusion Criteria:

  • Due to tinnitus/deafness/peripheral vertigo/peripheral facial paralysis in the ENT department of our hospital
  • Meet the ethical requirements of U-HRCT examination
  • Can cooperate with the completion of U-HRCT examination
  • Surgery in the ENT department of our hospital
  • At least one follow-up or re-examination after discharge

Exclusion Criteria:

  • History of previous ear surgery and trauma
  • CT image artifacts or incomplete scanning coverage
  • Incomplete clinical data

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Age under 18
Participants under the age of 18
Diagnostic test: ultra-high-resolution computed tomography exams
Participants in the age groups undergo ultra-high-resolution computed tomography exam
Age 18-30
Participants aged 18-30
Diagnostic test: ultra-high-resolution computed tomography exams
Participants in the age groups undergo ultra-high-resolution computed tomography exam
Age 31-40
Participants aged 31-40
Diagnostic test: ultra-high-resolution computed tomography exams
Participants in the age groups undergo ultra-high-resolution computed tomography exam
Age 41-50
Participants aged 41-50
Diagnostic test: ultra-high-resolution computed tomography exams
Participants in the age groups undergo ultra-high-resolution computed tomography exam
Age 51-60
Participants aged 51-60
Diagnostic test: ultra-high-resolution computed tomography exams
Participants in the age groups undergo ultra-high-resolution computed tomography exam
Age ≥61
Participants aged ≥61
Diagnostic test: ultra-high-resolution computed tomography exams
Participants in the age groups undergo ultra-high-resolution computed tomography exam

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Subjective and objective evaluation methods for CT image quality
Time Frame: 2022.1-2024.12
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
Time Frame: 2022.1-2024.12
diameters in milimeter
2022.1-2024.12
Radiological anatomy of normal ears based on ultra-high resolution CT
Time Frame: 2022.1-2024.12
angle in degree
2022.1-2024.12
Quantitative diagnostic standard for ear diseases based on U-HRCT image
Time Frame: 2022.1-2024.12
shape and position of conductive and senserineural hearing pathways
2022.1-2024.12
Quantitative diagnostic standard for ear diseases based on U-HRCT image
Time Frame: 2022.1-2024.12
size in milimeter of conductive and senserineural hearing pathways
2022.1-2024.12

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Beijing Friendship Hospital

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Beijing Tongren Hospital
Beijing Obstetrics and Gynecology Hospital

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Zhenchang Wang, Prof., Beijing Friendship Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 1, 2022

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2024

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 30, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 5, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 9, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 9, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 5, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2022-1-1111

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

IPD Plan Description

The project team has not decided the ways to share the data.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings