UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000032563 |
|---|---|
| Receipt number | R000037139 |
| Scientific Title | Visualization of endolymphatic hydrops in Meniere's disease by MRI |
| Date of disclosure of the study information | 2018/06/01 |
| Last modified on | 2018/05/13 13:29:52 |
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Basic information
Public title
Visualization of endolymphatic hydrops in Meniere's disease by MRI
Acronym
inner ear enhanced MRI
Scientific Title
Visualization of endolymphatic hydrops in Meniere's disease by MRI
Scientific Title:Acronym
inner ear enhanced MRI
Region
| Japan |
Condition
Condition
Meniere's disease and delayed endolymphatic hydrops
Classification by specialty
| Oto-rhino-laryngology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Visualization of endolymphatic hydrops in patients with Meniere's disease and delayed endolymphatic hydrops using by the enhanced MRI
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Grading of endolymphatic hydrops using by the MRI 4 hours after gadodiamide injection.
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
Getting MRI 4 hours after intravenous gadodiamide injection.
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients with Meniere's disease and delayed endolymphatic hydrops
Key exclusion criteria
Contraindication for gadodiamide injection
Target sample size
210
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hideo Shojaku |
Organization
University of Toyama
Division name
Department of Otolaryngology
Zip code
Address
2630 Sugitani, Toyama, Toyama
TEL
0764347368
hshojaku@med.u-toyama.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hideo Shojaku |
Organization
University of Toyama
Division name
Department of Otolaryngology
Zip code
Address
2630 Sugitani, Toyama, Toyama
TEL
0764347368
Homepage URL
hshojaku@med.u-toyama.ac.jp
Sponsor or person
Institute
University of Toyama
Institute
Department
Personal name
Funding Source
Organization
Self-raising
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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 | 06 | 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
Open public recruiting
Date of protocol fixation
| 2014 | Year | 09 | Month | 24 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 09 | Month | 24 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2018 | Year | 05 | Month | 12 | Day |
Last modified on
| 2018 | Year | 05 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037139
