UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000008310 |
|---|---|
| Receipt number | R000009787 |
| Scientific Title | Treatment effect evaluation of endolymphatic hydrops by inner ear contrast-enhanced MRI |
| Date of disclosure of the study information | 2012/06/30 |
| Last modified on | 2016/01/07 19:50:39 |
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Basic information
Public title
Treatment effect evaluation of endolymphatic hydrops by inner ear contrast-enhanced MRI
Acronym
Treatment effect evaluation of endolymphatic hydrops by inner ear contrast-enhanced MRI
Scientific Title
Treatment effect evaluation of endolymphatic hydrops by inner ear contrast-enhanced MRI
Scientific Title:Acronym
Treatment effect evaluation of endolymphatic hydrops by inner ear contrast-enhanced MRI
Region
| Japan |
Condition
Condition
Meniere's disease, Delayed endolymphatic hydrops
Classification by specialty
| Oto-rhino-laryngology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Endolymphatic hydrops in patients with intractable Meniere's disease will be evaluated by inner ear contrast-enhanced MRI. Pathogenic involvement of the 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 the MR image
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
Prevention
Type of intervention
| Medicine | Device,equipment |
Interventions/Control_1
Inner ear 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
| 75 | years-old | > |
Gender
Male and Female
Key inclusion criteria
# Definitive Meniere's disease or delayed endolymphatic hydrops
# Intractable case with frequent vertigo attacks (atleast once a month, for 6 months or over)
# No renal problem (less than 0.9mg/dl serum creatinine)
Key exclusion criteria
# Previous adverse experiences with (contrast-enhanced) MRI
# Braoncheal asthma symptoms within recent 10 years
# In pregnancy and preconception
# Other conditions considered as undesirable for entry in this clinica trial
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | UNO, Atsuhiko |
Organization
Osaka University
Division name
Otolaryngology, Head & Neck Surgery
Zip code
Address
2-2 Yamadaoka, Suita, Osaka 565-0871 Japan
TEL
06-6879-3951
auno@ent.med.osaka-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | IMAI, Takao |
Organization
Osaka University Hospital
Division name
Otolaryngology, Head and Neck Surgery
Zip code
Address
2-2 Yamadaoka, Suita, Osaka 565-0871 Japan
TEL
06-6879-5575
Homepage URL
timai@ent.med.osaka-u.ac.jp
Sponsor or person
Institute
Department of Otolaryngology, Head & Neck Surgery, Osaka University Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
None
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
大阪大学医学部附属病院（大阪府）
Other administrative information
Date of disclosure of the study information
| 2012 | Year | 06 | Month | 30 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Endolymphatic hydrops could be detected by Gadolinium (Gd) contrast-enhanced MRI. Using this method, we could showed some cases that endolymphatic hydrops was reduced after sac surgery. Gd contrast enhanced MRI can be a useful tool for assessment of the endolymphatic hydrops treatment.
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
Completed
Date of protocol fixation
| 2012 | Year | 02 | Month | 16 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2015 | Year | 12 | Month | 28 | Day |
Date of closure to data entry
| 2015 | Year | 12 | Month | 28 | Day |
Date trial data considered complete
| 2015 | Year | 12 | Month | 28 | Day |
Date analysis concluded
| 2015 | Year | 12 | Month | 28 | Day |
Other
Other related information
Management information
Registered date
| 2012 | Year | 06 | Month | 30 | Day |
Last modified on
| 2016 | Year | 01 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009787
