UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000037347 |
|---|---|
| Receipt number | R000042582 |
| Scientific Title | Development of diagnosis and treatment for vestibular diseases by equilibrium test |
| Date of disclosure of the study information | 2019/07/12 |
| Last modified on | 2019/07/12 15:34:04 |
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Basic information
Public title
Development of diagnosis and treatment for vestibular diseases by equilibrium test
Acronym
Equilibrium test
Scientific Title
Development of diagnosis and treatment for vestibular diseases by equilibrium test
Scientific Title:Acronym
Equilibrium test
Region
| Japan |
Condition
Condition
Equilibrium disorder
Classification by specialty
| Oto-rhino-laryngology | Adult | Child |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Diagnosis of equilibrium disorder by equilibrium test.
Basic objectives2
Others
Basic objectives -Others
Development of diagnosis and treatment.
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Diagnosis and treatment of equilibrium disorder.
Key secondary outcomes
Development of Development of diagnosis and treatment for equilibrium disorders.
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Self control
Stratification
YES
Dynamic allocation
YES
Institution consideration
Institution is considered as adjustment factor in dynamic allocation.
Blocking
YES
Concealment
Central registration
Intervention
No. of arms
1
Purpose of intervention
Diagnosis
Type of intervention
| Device,equipment |
Interventions/Control_1
Equilibrium test
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
| 10 | years-old | <= |
Age-upper limit
| 100 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Patients with vertigo/dizziness.
Key exclusion criteria
Patients who did not consent with equilibrium test.
Target sample size
1000
Research contact person
Name of lead principal investigator
| 1st name | Toru |
| Middle name | Toru |
| Last name | Miwa |
Organization
Kumamoto General Hospital
Division name
Otolaryngology-Head and Neck Surgery
Zip code
8668660
Address
10-10, Toricho, Yatsishiro, Japan
TEL
+81965327111
miw.com1101@gmail.com
Public contact
Name of contact person
| 1st name | Toru |
| Middle name | |
| Last name | Miwa |
Organization
Kumamoto University
Division name
Otolaryngology-Head and Neck Surgery
Zip code
8600811
Address
10-10, Toricho, Yatsishiro, Japan
TEL
+81963735255
Homepage URL
miw.com1101@gmail.com
Sponsor or person
Institute
Kumamoto General Hospital
Institute
Department
Personal name
Funding Source
Organization
Kumamoto General Hospital
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kumamoto General Hospital
Address
10-10 Toricho, YatsushiroJapan,
Tel
0965327111
miw.com1101@gmail.com
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
熊本総合病院
Other administrative information
Date of disclosure of the study information
| 2019 | Year | 07 | Month | 12 | 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
| 2017 | Year | 04 | Month | 01 | Day |
Date of IRB
| 2018 | Year | 06 | Month | 28 | Day |
Anticipated trial start date
| 2017 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2020 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2020 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2020 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2020 | Year | 03 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2019 | Year | 07 | Month | 12 | Day |
Last modified on
| 2019 | Year | 07 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042582
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
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