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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000006878
Receipt No. R000008015
Scientific Title Inner Ear Imaging Using Fiber Type Infra-red Optical Coherence Tomography
Date of disclosure of the study information 2011/12/13
Last modified on 2014/06/12

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Basic information
Public title Inner Ear Imaging Using Fiber Type Infra-red Optical Coherence Tomography
Acronym Inner Ear Imaging Using Fiber Type Infra-red Optical Coherence Tomography
Scientific Title Inner Ear Imaging Using Fiber Type Infra-red Optical Coherence Tomography
Scientific Title:Acronym Inner Ear Imaging Using Fiber Type Infra-red Optical Coherence Tomography
Region
Japan

Condition
Condition 1) Profound hearing impairment
2) Cholesteatoma with probable inner ear invasion
Classification by specialty
Oto-rhino-laryngology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Feasibility test of efficacy and improvement of the developed equipment
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Performance of the equipment
Key secondary outcomes 1) Structures in the inner ear
2) Destruction of inner ear structures by cholesteatoma invasion

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Diagnosis
Type of intervention
Device,equipment
Interventions/Control_1 Using the test device, images of inner ear structures are obtained at the time of cochlear implantation for profound hearing impairment
Interventions/Control_2 Using the test device, images of the destruction site of inner ear due to cholesteatoma extension are obtained at the time of the surgery
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 1) Patients who are scheduled for cochlear implant surgery at Kyoto University Hospital due to profound hearing impairment.
OR,
2) Patients who are scheduled for surgery at Kyoto University Hospital due to cholesteatoma with probable inner ear invasion.
Key exclusion criteria The doctor judged as inappropriate for this study.
Target sample size 6

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Juichi Ito
Organization Kyoto University Hospital
Division name Otolaryngology-Head and Neck Surgery
Zip code
Address Kawaharacho 54, Shogoin, Sakyo-ku, Kyoto, 606-8507, Japan
TEL 075-751-3346
Email coherence@ent.kuhp.kyoto-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Tatsunori Sakamoto
Organization Kyoto University Hospital
Division name Otolaryngology-Head and Neck Surgery
Zip code
Address Kawaharacho 54, Shogoin, Sakyo-ku, Kyoto, 606-8507, Japan
TEL 075-751-3346
Homepage URL
Email coherence@ent.kuhp.kyoto-u.ac.jp

Sponsor
Institute Kyoto University Hospital, Otolaryngology-Head and Neck Surgery
Institute
Department

Funding Source
Organization Hospital-Company collaboration support project for developing/improving problem-solving-type medical equipment
Organization
Division
Category of Funding Organization
Nationality of Funding Organization Japan

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 京都大学医学部附属病院(京都府)

Other administrative information
Date of disclosure of the study information
2011 Year 12 Month 13 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 Enrolling by invitation
Date of protocol fixation
2011 Year 12 Month 12 Day
Date of IRB
Anticipated trial start date
2012 Year 01 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2011 Year 12 Month 12 Day
Last modified on
2014 Year 06 Month 12 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008015

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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