UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000023858 |
|---|---|
| Receipt number | 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 20:24:01 |
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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
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
ty@hama-med.ac.jp
Sponsor or person
Institute
Hamamatsu Unversity School of Medicine
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027289
