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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000035138
Receipt No. R000040050
Official scientific title of the study Evaluation of the precision in image diagnosis of cholesteatoma
Date of disclosure of the study information 2018/12/04
Last modified on 2018/12/04

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Basic information
Official scientific title of the study Evaluation of the precision in image diagnosis of cholesteatoma
Title of the study (Brief title) Image diagnosis of cholesteatoma
Region
Japan

Condition
Condition cholesteatoma
Classification by specialty
Oto-rhino-laryngology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 to evaluate the precision in fusion images of CT and MRI
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Explanatory
Developmental phase

Assessment
Primary outcomes Precision in diagnosis of cholesteatoma by fusion images of CT and MRI
Key secondary outcomes diagnosis in each part of middle ear

Base
Study type Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit

Not applicable
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria patients who undergo planned tympanoplasty for cholesteatoma
Key exclusion criteria patients who cannot undergo MRI
patients who are judged unsutable for this study
Target sample size 50

Research contact person
Name of lead principal investigator Yumi Ohta
Organization Osaka university
Division name otorhinolaryngology and head and neck surgery
Address 2-2 Yamadaoka Suita Osaka, Japan
TEL 06-6879-3951
Email yota@ent.med.osaka-u.ac.jp

Public contact
Name of contact person Yumi Ohta
Organization Osaka University
Division name otorhinolaryngology and head and neck surgery
Address 2-2 Yamadaoka Suita Osaka, Japan
TEL 06-6879-3951
Homepage URL
Email yota@ent.med.osaka-u.ac.jp

Sponsor
Institute Osaka university
Institute
Department

Funding Source
Organization none
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

Secondary IDs
Secondary IDs NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information
2018 Year 12 Month 04 Day

Progress
Recruitment status Enrolling by invitation
Date of protocol fixation
2017 Year 07 Month 04 Day
Anticipated trial start date
2017 Year 07 Month 04 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results Unpublished
URL releasing results
Results
Other related information continue enrolling in this study

Management information
Registered date
2018 Year 12 Month 04 Day
Last modified on
2018 Year 12 Month 04 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040050

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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