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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000030055
Receipt No. R000034317
Scientific Title VSB for unilateral conductive or mixed hearing loss
Date of disclosure of the study information 2017/11/21
Last modified on 2017/11/21

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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
Email 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
Email nishio@shinshu-u.ac.jp

Sponsor
Institute Shinshu University School of Medicine
Institute
Department

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
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
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 Open public recruiting
Date of protocol fixation
2016 Year 06 Month 28 Day
Date of IRB
Anticipated trial start date
2016 Year 07 Month 09 Day
Last follow-up date
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
2017 Year 11 Month 21 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034317

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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