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UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000032430
Receipt No. R000036981
Scientific Title Treatment effect evaluation of endolymphatic hydrops by inner ear contrast-enhanced MRI
Date of disclosure of the study information 2018/04/30
Last modified on 2019/05/01

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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
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 100

Research contact person
Name of lead principal investigator
1st name TAKAO
Middle name
Last name IMAI
Organization Osaka University
Division name Otolaryngology, Head & Neck Surgery
Zip code 565-0871
Address 2-2 Yamadaoka, Suita, Osaka 565-0871 Japan
TEL 06-6879-3951
Email timai@ent.med.osaka-u.ac.jp

Public contact
Name of contact person
1st name Takao
Middle name
Last name IMAI
Organization Osaka University Hospital
Division name Otolaryngology, Head and Neck Surgery
Zip code 565-0871
Address 2-2 Yamadaoka, Suita, Osaka 565-0871 Japan
TEL 06-6879-5575
Homepage URL
Email timai@ent.med.osaka-u.ac.jp

Sponsor
Institute Osaka University Graduate School of Medicine
Institute
Department

Funding Source
Organization Osaka University Graduate School of Medicine
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
Address 2-2 Yamadaoka, Suita, Osaka 565-0871 Japan
Tel 06-6879-5111
Email rinri@hp-crc.med.osaka-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 04 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
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
2012 Year 06 Month 07 Day
Date of IRB
2012 Year 06 Month 07 Day
Anticipated trial start date
2018 Year 04 Month 30 Day
Last follow-up date
2022 Year 12 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 04 Month 30 Day
Last modified on
2019 Year 05 Month 01 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036981

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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