UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000023544 |
|---|---|
| Receipt number | R000027117 |
| Scientific Title | Evaluation of endolymphatic hydrops in patients with Meniere's disease using contrast-enhanced MRI |
| Date of disclosure of the study information | 2016/10/01 |
| Last modified on | 2016/08/08 15:25:33 |
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Basic information
Public title
Evaluation of endolymphatic hydrops in patients with Meniere's disease using contrast-enhanced MRI
Acronym
Evaluation of endolymphatic hydrops using contrast-enhanced MRI
Scientific Title
Evaluation of endolymphatic hydrops in patients with Meniere's disease using contrast-enhanced MRI
Scientific Title:Acronym
Evaluation of endolymphatic hydrops using contrast-enhanced MRI
Region
| Japan |
Condition
Condition
Meniere's Disease
Classification by specialty
| Oto-rhino-laryngology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Endolymphatic hydrops in patients with Meniere's disease will be evaluated by contrast-enhanced MRI. Pathogenic involvement of the endolymphatic hydrops and treatment effects on the hydrops will be examined.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Endolymphatic hydrops on contrast-enhanced MRI
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
| Medicine | Device,equipment |
Interventions/Control_1
contrast-enhanced 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
| 20 | years-old | <= |
Age-upper limit
| 80 | years-old | > |
Gender
Male and Female
Key inclusion criteria
patients with Meniere's disease
Key exclusion criteria
# previous adverse experiences with (contrast-enhanced) MRI
# paitent with broncheal asthma symptoms within recent 10 years
# pregnancy and preconception
# other conditions considered as undesirable for entry in this clinical trial
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Koichi Omori |
Organization
Kyoto University, Graduate School of Medicine
Division name
Department of Otolaryngology, Head and Neck Surgery
Zip code
Address
54 Shogoin Kawaharacho, Sakyo, Kyoto
TEL
075-751-3346
omori@ent.kuhp.kyoto-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Takayuki Okano |
Organization
Kyoto University, Graduate School of Medicine
Division name
Department of Otolaryngology, Head and Neck Surgery
Zip code
Address
54 Shogoin Kawaharacho, Sakyo, Kyoto
TEL
075-751-3346
Homepage URL
tokano@ent.kuhp.kyoto-u.ac.jp
Sponsor or person
Institute
Kyoto University
Institute
Department
Personal name
Funding Source
Organization
Kyoto University
Organization
Division
Category of Funding Organization
Japanese Governmental office
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
| 2016 | Year | 10 | 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
| 2016 | Year | 08 | Month | 08 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 10 | Month | 01 | 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
| 2016 | Year | 08 | Month | 08 | Day |
Last modified on
| 2016 | Year | 08 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027117
