UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000033179 |
|---|---|
| Receipt number | R000037692 |
| Scientific Title | Magnetic resonance imaging evaluation of permeability of inner ear with endolymphatic hydrops |
| Date of disclosure of the study information | 2018/09/01 |
| Last modified on | 2023/07/03 05:45:41 |
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Basic information
Public title
Magnetic resonance imaging evaluation of permeability of inner ear with endolymphatic hydrops
Acronym
Permeability of inner ear with endolymphatic hydrops
Scientific Title
Magnetic resonance imaging evaluation of permeability of inner ear with endolymphatic hydrops
Scientific Title:Acronym
Permeability of inner ear with endolymphatic hydrops
Region
| Japan |
Condition
Condition
endolymphatic hydrops and related disease
Classification by specialty
| Oto-rhino-laryngology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the permeability of inner ear with endolymphatic hydrops and related disease
Basic objectives2
Others
Basic objectives -Others
To evaluate the endolymphatic hydrops
Trial characteristics_1
Exploratory
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
the permeability of inner ear
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
| Other |
Interventions/Control_1
MRI
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
| 15 | years-old | <= |
Age-upper limit
| 85 | years-old | > |
Gender
Male and Female
Key inclusion criteria
endolymphatic hydrops and related disease
Key exclusion criteria
Asthma
impairment of renal function
allergy of contrast agent
Target sample size
80
Research contact person
Name of lead principal investigator
| 1st name | Michihiko |
| Middle name | |
| Last name | Sone |
Organization
Nagoya university
Division name
Otorhinolarungology
Zip code
4668550
Address
65, tsurumai-cho, showa-ku, nagaya
TEL
052-744-2323
michsone@med.nagoya-u.ac.jp
Public contact
Name of contact person
| 1st name | Tadao |
| Middle name | |
| Last name | Yoshida |
Organization
Nagoya university
Division name
Otorhinolarungology
Zip code
4668550
Address
65, tsurumai-cho, showa-ku, nagaya
TEL
052-744-2323
Homepage URL
tadaoy@med.nagoya-u.ac.jp
Sponsor or person
Institute
Nagoya university
Institute
Department
Personal name
Funding Source
Organization
Nagoya university
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
Nagoya University Graduate School of Medicine
Address
65, tsurumai, showa-ku, Nagoya
Tel
052-744-2111
tadaoy@med.nagoya-u.ac.jp
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
| 2018 | Year | 09 | 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
Enrolling by invitation
Date of protocol fixation
| 2018 | Year | 06 | Month | 27 | Day |
Date of IRB
| 2018 | Year | 10 | Month | 24 | Day |
Anticipated trial start date
| 2018 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2025 | 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
| 2018 | Year | 06 | Month | 28 | Day |
Last modified on
| 2023 | Year | 07 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037692
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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