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Name:
UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000023858
Receipt No. R000027289
Scientific Title The effect of Hybrid cochlear implant
Date of disclosure of the study information 2016/09/10
Last modified on 2019/03/24

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Basic information
Public title The effect of Hybrid cochlear implant
Acronym The effect of Hybrid cochlear implant
Scientific Title The effect of Hybrid cochlear implant
Scientific Title:Acronym The effect of Hybrid cochlear implant
Region
Japan

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

Objectives
Narrative objectives1 We want to evaluate the effect of using hybrid cochlear implant in the case of using Japanese.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes The improvement of audiogram and speech intelligibility test
Key secondary outcomes

Base
Study type Interventional

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

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Device,equipment
Interventions/Control_1 To use the hybrid cochlear implant
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
1 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Advanced sensorineural hearing loss Patients.Cases which are invalid to use of hearing aids and considered an indication for cochlear implant surgery.
Key exclusion criteria Patients with serious complications
Patients Who the doctor has determined that inappropriate
Patients who consent has not been obtained
Target sample size 3

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Takashi Yamatodani
Organization Hamamatsu Unversity School of Medicine
Division name Otorhinolaryngology/Head and neck Surgery
Zip code
Address 1-20-1 Handayama Higashiku Hamamatsu Sizuoka
TEL 053-435-2252
Email ty@hama-med.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Takashi Yamatodani
Organization Hamamatsu Unversity School of Medicine
Division name Otorhinolaryngology/Head and neck Surgery
Zip code
Address 1-20-1 Handayama Higashiku Hamamatsu Sizuoka
TEL 053-435-2252
Homepage URL
Email ty@hama-med.ac.jp

Sponsor
Institute Hamamatsu Unversity School of Medicine
Institute
Department

Funding Source
Organization Hamamatsu Unversity School of Medicine
Organization
Division
Category of Funding Organization Self funding
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
2016 Year 09 Month 10 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 Terminated
Date of protocol fixation
2016 Year 08 Month 31 Day
Date of IRB
2016 Year 07 Month 11 Day
Anticipated trial start date
2016 Year 11 Month 22 Day
Last follow-up date
2019 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2016 Year 08 Month 31 Day
Last modified on
2019 Year 03 Month 24 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027289

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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