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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000035512
Receipt No. R000039024
Scientific Title Development of ossicular mobility device using artificail intelligence
Date of disclosure of the study information 2019/01/11
Last modified on 2019/01/11

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Basic information
Public title Development of ossicular mobility device using artificail intelligence
Acronym ossicular mobility device
Scientific Title Development of ossicular mobility device using artificail intelligence
Scientific Title:Acronym ossicular mobility device
Region
Japan

Condition
Condition conductive mixed hearing loss
Classification by specialty
Oto-rhino-laryngology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The low mobility of the ossicules affects sound transmission efficiency.We find out how measurement of mobility during surgery affects postoperative hearing.
Basic objectives2 Others
Basic objectives -Others Collecting hearing or audiological data at pre- and at post-operation and operative finings from previosly operated surgery(tympanoplasty,stapedectomy and stapedotomy) which we have not measured ossicular mobility.
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes hearing before and after surgery
Key secondary outcomes

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
20 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria conductive or mixed hearing loss (middle ear disease )
Key exclusion criteria less than 20 years old
Target sample size 400

Research contact person
Last name of lead principal investigator
1st name
Middle name
Last name Sho Kanzaki
Organization Keio University School of medicine
Division name Dept. Otolaryngology
Zip code
Address 35 Shinanomachi Shinjuku Tokyo
TEL 0353633827
Email skan@keio.jp

Public contact
1st name of contact person
1st name
Middle name
Last name Sho Kanzaki
Organization Keio University School of medicine
Division name Otolaryngology
Zip code
Address 35 Shinanomachi Shinjuku Tokyo
TEL 0353633827
Homepage URL
Email skan@keio.jp

Sponsor
Institute Keio University School of Medicine
Institute
Department

Funding Source
Organization Ministry of Economy, Trade and Industry
Organization
Division
Category of Funding Organization Japanese Governmental office
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization
Address
Tel
Email

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
2019 Year 01 Month 11 Day

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Preinitiation
Date of protocol fixation
2018 Year 09 Month 21 Day
Date of IRB
Anticipated trial start date
2019 Year 01 Month 11 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information ossicles mobility during surgery and differences between pre and post hearing, etc.

Management information
Registered date
2019 Year 01 Month 11 Day
Last modified on
2019 Year 01 Month 11 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039024

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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