UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000006878 |
|---|---|
| Receipt number | 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 13:55:50 |
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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
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
coherence@ent.kuhp.kyoto-u.ac.jp
Sponsor or person
Institute
Kyoto University Hospital, Otolaryngology-Head and Neck Surgery
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008015
