UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000040668 |
|---|---|
| Receipt number | R000046419 |
| Scientific Title | 7T MRI in sudden deafness |
| Date of disclosure of the study information | 2020/06/08 |
| Last modified on | 2024/04/26 09:27:26 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
7T MRI in sudden deafness
Acronym
7T MRI in sudden deafness
Scientific Title
7T MRI in sudden deafness
Scientific Title:Acronym
7T MRI in sudden deafness
Region
| Japan |
Condition
Condition
sudden deafness
Classification by specialty
| Oto-rhino-laryngology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To clarify the pathophysiology of sudden deafness using 7T MRI
Basic objectives2
Others
Basic objectives -Others
To see the change of the endolymph and perilymph
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
To see the change of signal intensity in the endolymphatic space and perilymphatic space
Key secondary outcomes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| 80 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Those fulfilling the criteria established by the Sudden Deafness Research Committee of the Ministry of Health and Welfare, Japan (2015)
Key exclusion criteria
1) Those with metal within the body
2) Those with claustrophobia
3) Those who can not stay still more than 45 minutes
4) Those who are or may be pregnant
5) Those who did not agree to participate in this study
6) Those who were judged to be inappropriate for this study
In cases using gadolinium
7) Those who had experienced adverse reaction to the gadolinium
8) Those with bronchial asthma
9) Those with or may with epilepsy
10) Those with sever liver or kidney diseases
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Harukazu |
| Middle name | |
| Last name | Hiraumi |
Organization
Iwate Medical University
Division name
Otolaryngology
Zip code
028-3695
Address
2-1-1, idai doori, Yahaba City, Shiwa, Iwate, Japan
TEL
0196137111
hhiraumi@iwate-med.ac.jp
Public contact
Name of contact person
| 1st name | Harukazu |
| Middle name | |
| Last name | Hiraumi |
Organization
Iwate Medical University
Division name
Otolaryngology
Zip code
0283695
Address
2-1-1, idai doori, Yahaba City, Shiwa, Iwate, Japan
TEL
0196137111
Homepage URL
hhiraumi@iwate-med.ac.jp
Sponsor or person
Institute
Iwate Medical University
Institute
Department
Personal name
Funding Source
Organization
self funding
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
Iwate Medical University
Address
2-1-1, idai doori, Yahaba City, Shiwa, Iwate, Japan
Tel
0196137111
kenkyu-rinri@j.iwate-med.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
岩手医科大学
Other administrative information
Date of disclosure of the study information
| 2020 | Year | 06 | Month | 08 | 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
Terminated
Date of protocol fixation
| 2020 | Year | 05 | Month | 26 | Day |
Date of IRB
| 2020 | Year | 11 | Month | 24 | Day |
Anticipated trial start date
| 2020 | Year | 06 | Month | 30 | Day |
Last follow-up date
| 2022 | Year | 04 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
To analyze the image of the inner ear of patients with sudden deafness using 7T MRI (Discovery MR950, GE healthcare)
Management information
Registered date
| 2020 | Year | 06 | Month | 05 | Day |
Last modified on
| 2024 | Year | 04 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046419
