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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000007659
Receipt No. R000009030
Scientific Title The clinical evaluation of the middle ear pressure therapy for intractable Meniere disease.
Date of disclosure of the study information 2012/05/10
Last modified on 2012/04/04

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Basic information
Public title The clinical evaluation of the middle ear pressure therapy for intractable Meniere disease.
Acronym The middle ear pressure therapy for intractable Meniere disease.
Scientific Title The clinical evaluation of the middle ear pressure therapy for intractable Meniere disease.
Scientific Title:Acronym The middle ear pressure therapy for intractable Meniere disease.
Region
Japan

Condition
Condition Intractable Meniere disease
Classification by specialty
Oto-rhino-laryngology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To evaluate the clinical benefit of middle ear presssure therapy for intractable Meniere disease.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Explanatory
Developmental phase Not applicable

Assessment
Primary outcomes The frequency of vertigo, Functional level scale
Key secondary outcomes DHI(dizziness handicap inventory)

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 Treatment
Type of intervention
Device,equipment
Interventions/Control_1 middle ear pressure tehrapy
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
8 years-old <=
Age-upper limit
90 years-old >=
Gender Male and Female
Key inclusion criteria Fnctional level scale is more than 3.
Key exclusion criteria The case without informed consent.
Target sample size 30

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Fumiyuki Goto
Organization NHO Tokyo Medical Center
Division name otolaryngology
Zip code
Address 2-5-1 Higashigaoka meguro
TEL 03-3411-0111
Email

Public contact
Name of contact person
1st name
Middle name
Last name FUMIYUKI GOTO
Organization NHO TMC
Division name otolaryngology
Zip code
Address
TEL
Homepage URL
Email amifumi@bc5.so-net.ne.jp

Sponsor
Institute TMC
Institute
Department

Funding Source
Organization TMC
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
Email

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
2012 Year 05 Month 10 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
2012 Year 04 Month 05 Day
Date of IRB
Anticipated trial start date
2012 Year 05 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
2012 Year 04 Month 04 Day
Last modified on
2012 Year 04 Month 04 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009030

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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