UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000038426 |
|---|---|
| Receipt number | 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 14:56:42 |
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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
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
t-miwa@kitano-hp.or.jp
Sponsor or person
Institute
Kitano hospital, Tazuke Kofukai Medical Research Institute
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043773
