UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000035512 |
|---|---|
| Receipt number | R000039024 |
| Scientific Title | Development of ossicular mobility device using artificail intelligence |
| Date of disclosure of the study information | 2019/01/11 |
| Last modified on | 2021/04/17 03:12:36 |
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Basic information
Public title
Development of ossicular mobility device using artificail intelligence
Acronym
ossicular mobility device
Scientific Title
Development of ossicular mobility device using artificail intelligence
Scientific Title:Acronym
ossicular mobility device
Region
| Japan |
Condition
Condition
conductive mixed hearing loss
Classification by specialty
| Oto-rhino-laryngology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The low mobility of the ossicules affects sound transmission efficiency.We find out how measurement of mobility during surgery affects postoperative hearing.
Basic objectives2
Others
Basic objectives -Others
Collecting hearing or audiological data at pre- and at post-operation and operative finings from previosly operated surgery(tympanoplasty,stapedectomy and stapedotomy) which we have not measured ossicular mobility.
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
hearing before and after surgery
Key secondary outcomes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
conductive or mixed hearing loss (middle ear disease )
Key exclusion criteria
less than 20 years old
Target sample size
400
Research contact person
Name of lead principal investigator
| 1st name | Sho |
| Middle name | |
| Last name | Kanzaki |
Organization
Keio University School of medicine
Division name
Dept. Otolaryngology
Zip code
160-8586
Address
35 Shinanomachi Shinjuku Tokyo
TEL
+81353633827
skan@a7.keio.jp
Public contact
Name of contact person
| 1st name | Sho |
| Middle name | |
| Last name | Kanzaki |
Organization
Keio University School of medicine
Division name
Otolaryngology
Zip code
160-8582
Address
35 Shinanomachi Shinjuku Tokyo
TEL
0353633827
Homepage URL
skan@keio.jp
Sponsor or person
Institute
Keio University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Ministry of Economy, Trade and Industry
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Keio University
Address
35 Shinanomachi shinjuku Tokyo
Tel
+81353633827
skan@keio.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
| 2019 | Year | 01 | Month | 11 | 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
Open public recruiting
Date of protocol fixation
| 2018 | Year | 09 | Month | 21 | Day |
Date of IRB
| 2018 | Year | 09 | Month | 26 | Day |
Anticipated trial start date
| 2019 | Year | 01 | Month | 11 | Day |
Last follow-up date
| 2023 | Year | 04 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
ossicles mobility during surgery and differences between pre and post hearing, etc.
Management information
Registered date
| 2019 | Year | 01 | Month | 11 | Day |
Last modified on
| 2021 | Year | 04 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039024
