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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000038426
Receipt No. R000043773
Scientific Title Clinical trial of equilibrium utilizing vestibular stimulation
Date of disclosure of the study information 2019/12/01
Last modified on 2019/10/29

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Basic information
Public title Clinical research of equilibrium utilizing eequilibrium test and vestibular stimulation
Acronym Clinical research of equilibrium
Scientific Title Clinical trial of equilibrium utilizing vestibular stimulation
Scientific Title:Acronym EVS
Region
Japan

Condition
Condition Disequilibrium
Classification by specialty
Neurology Oto-rhino-laryngology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Development of therapy for vestibular disorders and disequilibrium
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Development of therapy for disequilibrium
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Double blind -all involved are blinded
Control Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Prevention
Type of intervention
Device,equipment Maneuver
Interventions/Control_1 Vestibular stimulation
Interventions/Control_2 Equilibrium test
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
12 years-old <
Age-upper limit
100 years-old >=
Gender Male and Female
Key inclusion criteria Patients suffering from disequilibrium
Key exclusion criteria Rejection of vestibular test and stimulation
Target sample size 500

Research contact person
Name of lead principal investigator
1st name Toru
Middle name
Last name Miwa
Organization Kitano hospital, Tazuke Kofukai Medical Research Institute
Division name Otolaryngology-Head and Neck Surgery
Zip code 5308480
Address 2-4-20 Ougi-machi, Kita-ku, Osaka
TEL +81663121221
Email t-miwa@kitano-hp.or.jp

Public contact
Name of contact person
1st name Toru
Middle name Miwa
Last name Miwa
Organization Kitano hospital. Tazuke Kofukai Medical Research Institute
Division name Otolaryngology-Head and Neck Surgery
Zip code 530-8480
Address 2-4-20 Ougi-machi, Kita-ku, Osaka
TEL 0663121221
Homepage URL
Email t-miwa@kitano-hp.or.jp

Sponsor
Institute Kitano hospital, Tazuke Kofukai Medical Research Institute
Institute
Department

Funding Source
Organization Kitano hospital, Tazuke Kofukai Medical Research Institute
Organization
Division
Category of Funding Organization Non profit foundation
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization Kitano hospital, Tazuke Kofukai Medical Research Institute
Address 2-4-20 Ougi-machi, Kita-ku, Osaka
Tel +81663121221
Email t-miwa@kitano-hp.or.jp

Secondary IDs
Secondary IDs YES
Study ID_1 138
Org. issuing International ID_1 Kumamoto General Hospital
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 12 Month 01 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
2019 Year 10 Month 01 Day
Date of IRB
Anticipated trial start date
2019 Year 11 Month 01 Day
Last follow-up date
2022 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
2019 Year 10 Month 29 Day
Last modified on
2019 Year 10 Month 29 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043773

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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