UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000053198 |
|---|---|
| Receipt number | R000060714 |
| Scientific Title | The Research on Cochlear Microphonic monitoring during EAS and Cochlear Implant Surgery using OTOPLAN System |
| Date of disclosure of the study information | 2023/12/24 |
| Last modified on | 2023/12/22 14:58:02 |
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Basic information
Public title
The Research on Cochlear Microphonic monitoring during EAS and Cochlear Implant Surgery using OTOPLAN System
Acronym
The Cochlear Microphonic monitoring using OTOPLAN System
Scientific Title
The Research on Cochlear Microphonic monitoring during EAS and Cochlear Implant Surgery using OTOPLAN System
Scientific Title:Acronym
The Cochlear Microphonic monitoring using OTOPLAN System
Region
| Japan |
Condition
Condition
bilateral sensorineural hearing loss
Classification by specialty
| Oto-rhino-laryngology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to conduct cochlear microphonic monitoring during EAS and cochlear implant surgery using the cochlear implant mapping system (MAESTRO 9 AS) and DATAMAN, and to evaluate the utility of combining these with the OTOPLAN system.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The correlation between electrode positions in OTOPLAN and the charge levels in mapping
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
Diagnosis
Type of intervention
| Device,equipment |
Interventions/Control_1
Performing cochlear microphonic monitg using the cochlear implant mapping system (MAESTRO 9 AS) and DATAMAN, which measure neural response telemetry during cochlear implant and EAS surgery
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
Cases diagnosed as candidates for cochlear implant or EAS due to hearing impairment
Key exclusion criteria
Cases with inner ear malformations.
Cases with systemic complications.
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Masahiro |
| Middle name | |
| Last name | Takahashi |
Organization
International University of Health and Welfare, Mita hospital
Division name
Otorhinolaryngology
Zip code
108-8329
Address
1-4-3. Mita Minato-ku, Tokyo
TEL
03-3451-8121
masa12_1@iuhw.ac.jp
Public contact
Name of contact person
| 1st name | Masahiro |
| Middle name | |
| Last name | Takahashi |
Organization
International University of Health and Welfare, Mita hospital
Division name
Otorhinolaryngology
Zip code
108-8329
Address
1-4-3. Mita Minato-ku, Tokyo
TEL
03-3451-8121
Homepage URL
masa12_1@iuhw.ac.jp
Sponsor or person
Institute
International University of Health and Welfare, Mita hospital
Institute
Department
Personal name
Funding Source
Organization
International University of Health and Welfare, Mita hospital
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
International University of Health and Welfare
Address
1-4-3. Mita Minato-ku, Tokyo
Tel
03-3451-8121
rinri-mita@iuhw.ac.jp
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
| 2023 | Year | 12 | Month | 24 | 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
| 2023 | Year | 12 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2024 | Year | 01 | Month | 09 | Day |
Last follow-up date
| 2027 | Year | 12 | 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
| 2023 | Year | 12 | Month | 22 | Day |
Last modified on
| 2023 | Year | 12 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000060714
