UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000020047 |
|---|---|
| Receipt number | R000023153 |
| Scientific Title | Eye movement analysis for diagnosis of disease complaining with vertigo |
| Date of disclosure of the study information | 2015/12/03 |
| Last modified on | 2020/06/07 09:16:40 |
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Basic information
Public title
Eye movement analysis for diagnosis of disease complaining with vertigo
Acronym
Eye movement analysis of patients with vertigo
Scientific Title
Eye movement analysis for diagnosis of disease complaining with vertigo
Scientific Title:Acronym
Eye movement analysis of patients with vertigo
Region
| Japan |
Condition
Condition
disease complaining with vertigo
Classification by specialty
| Oto-rhino-laryngology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
By analyzing the abnormal eye movement using our own eye movement analysis system quantitatively the pathology of disease complaining with vertigo is made clear.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
the data of eye movement
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
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Diagnosis
Type of intervention
| Device,equipment |
Interventions/Control_1
We use our own eye movement analysis system.
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
| 1 | years-old | <= |
Age-upper limit
| 100 | years-old | > |
Gender
Male and Female
Key inclusion criteria
outpatients who have medical examinations at our hospital
Key exclusion criteria
patients who do not approve this research
Target sample size
150
Research contact person
Name of lead principal investigator
| 1st name | Takao |
| Middle name | |
| Last name | Imai |
Organization
Osaka University Graduate School of Medicine
Division name
Department of Otorhinolaryngology - Head and Neck Surgery
Zip code
565-0871
Address
2-2 Yamadaoka, Suita-shi, Osaka, Japan
TEL
+81-6-6879-3951
timai@ent.med.osaka-u.ac.jp
Public contact
Name of contact person
| 1st name | Takao |
| Middle name | |
| Last name | Imai |
Organization
Osaka University Graduate School of Medicine
Division name
Department of Otorhinolaryngology - Head and Neck Surgery
Zip code
565-0871
Address
2-2 Yamadaoka, Suita-shi, Osaka, Japan
TEL
06-6879-3951
Homepage URL
http://www.med.osaka-u.ac.jp/pub/ent/
timai@ent.med.osaka-u.ac.jp
Sponsor or person
Institute
Department of Otorhinolaryngology - Head and Neck Surgery, Osaka University Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Osaka University Hospital
Address
2-15 Yamadaoka, Suita-shi, Osaka
Tel
06-6879-5111
rinri@hp-crc.med.osaka-u.ac.jp
Secondary IDs
Secondary IDs
YES
Study ID_1
10091
Org. issuing International ID_1
Osaka University Hospital
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
大阪大学医学部附属病院、大阪労災病院
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 12 | Month | 03 | 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
| 2015 | Year | 12 | Month | 03 | Day |
Date of IRB
| 2015 | Year | 12 | Month | 03 | Day |
Anticipated trial start date
| 2015 | Year | 12 | Month | 03 | Day |
Last follow-up date
| 2022 | Year | 12 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2015 | Year | 12 | Month | 03 | Day |
Last modified on
| 2020 | Year | 06 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023153
| 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 |
