UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000002482 |
|---|---|
| Receipt number | 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 15:11:07 |
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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
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
Sponsor or person
Institute
Department of Otorhinolaryngology
Nagoya University School of Medicine
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003032
