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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000002482
Receipt No. R000003032
Scientific Title Investigation on permeability of the round window and size of the membranous labyrinth with use of intratympanic gadolinium administration
Date of disclosure of the study information 2009/09/11
Last modified on 2009/09/11

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Basic information
Public title Investigation on permeability of the round window and size of the membranous labyrinth with use of intratympanic gadolinium administration
Acronym Magnetic resonance imaging after intratympanic gadolinium administration
Scientific Title Investigation on permeability of the round window and size of the membranous labyrinth with use of intratympanic gadolinium administration
Scientific Title:Acronym Magnetic resonance imaging after intratympanic gadolinium administration
Region
Japan

Condition
Condition Hearing loss or vertigo due to inner ear diseases
Classification by specialty
Oto-rhino-laryngology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To visualize endolymphatic hydrops and evaluate the degree of the hydrops. Recently intratympanic drug administration therapy has been used for the treatment of various inner ear diseases. Another purpose of this study is to investigate the permeability of the round window membrane.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Presence or absence of the endolymphatic hydrops
Degree of the endolymphatic hydrops
Permeability of the round window membrane
Adverse effect
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 Maneuver
Interventions/Control_1 Intratympanic gadolinium administration through the tympanic membrane
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 intractable sudden deafness before intratympanic steroid injection.
Patients with suspected Meniere's disease.
Patients with intractable Meniere's disease before intratympanic gentamicin therapy.
Key exclusion criteria Patients with otitis media.
Target sample size 175

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Tsutomu Nakashima
Organization Nagoya University School of Medicine
Division name Department of Otorhinolaryngology
Zip code
Address 65, Tsurumai-cho, Showa-ku, Nagoya
TEL 052-744-2323
Email

Public contact
Name of contact person
1st name
Middle name
Last name
Organization Nagoya University School of Medicine
Division name Department of Otorhinolaryngology
Zip code
Address
TEL 052-744-2323
Homepage URL
Email

Sponsor
Institute Department of Otorhinolaryngology
Nagoya University School of Medicine
Institute
Department

Funding Source
Organization Research Grants from the Ministry of Health, Labour and Welfare in Japan (Researches on Sensory and Communicative Disorders)
Organization
Division
Category of Funding Organization
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
2009 Year 09 Month 11 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
2006 Year 05 Month 12 Day
Date of IRB
Anticipated trial start date
2006 Year 05 Month 01 Day
Last follow-up date
2013 Year 03 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2009 Year 09 Month 11 Day
Last modified on
2009 Year 09 Month 11 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003032

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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