UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000030055 |
|---|---|
| Receipt number | R000034317 |
| Scientific Title | VSB for unilateral conductive or mixed hearing loss |
| Date of disclosure of the study information | 2017/11/21 |
| Last modified on | 2022/12/06 12:31:39 |
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Basic information
Public title
VSB for unilateral conductive or mixed hearing loss
Acronym
VSB for unilateral conductive or mixed hearing loss
Scientific Title
VSB for unilateral conductive or mixed hearing loss
Scientific Title:Acronym
VSB for unilateral conductive or mixed hearing loss
Region
| Japan |
Condition
Condition
Unilateral conductive hearing loss
Unilateral mixed hearing loss
Classification by specialty
| Oto-rhino-laryngology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the clinical utility, safety, and effectiveness of VSB for unilateral conductive or unilateral mixed hearing loss cases.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The therapeutic effects are evaluated at 12 month after VSB surgely using free field audiometoly. 20dB or more threshold recovery regarded as effective cases.
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
Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
Set the flowing mass transducer of VSB system on the round window by operation.
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
| 4 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patient fulfill the below bone conduction hearing thresholds.
500Hz:45dB or less
1000Hz:50dB or less
2000Hz:65dB or less
4000Hz:65dB or less
Key exclusion criteria
1) Patients with highly malformation of cochlear or temporal bones.
2) Patients do not use general anesthesia.
Target sample size
5
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hiroaki Suzuki |
Organization
Shinshu University School of Medicine
Division name
Department of Otorhinolaryngology
Zip code
Address
3-1-1 Asahi Matsumoto
TEL
0263-37-2666
nishio@shinshu-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Shin-ya Nishio |
Organization
Shinshu University School of Medicine
Division name
Department of Otorhinolaryngology
Zip code
Address
3-1-1 Asahi Matsumoto
TEL
0263-37-2666
Homepage URL
nishio@shinshu-u.ac.jp
Sponsor or person
Institute
Shinshu University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Shinshu University Hospital
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
International University of Health and Welfar, Mita Hospital
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
| 2017 | Year | 11 | Month | 21 | 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
Completed
Date of protocol fixation
| 2016 | Year | 06 | Month | 28 | Day |
Date of IRB
| 2016 | Year | 08 | Month | 17 | Day |
Anticipated trial start date
| 2016 | Year | 07 | Month | 09 | Day |
Last follow-up date
| 2021 | Year | 06 | Month | 03 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2017 | Year | 11 | Month | 21 | Day |
Last modified on
| 2022 | Year | 12 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034317
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
