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UMIN-CTR Clinical Trial |
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Name: | UMIN ID: |
Recruitment status | Enrolling by invitation |
Unique ID issued by UMIN | UMIN000040668 |
Receipt No. | R000046419 |
Scientific Title | 7T MRI in sudden deafness |
Date of disclosure of the study information | 2020/06/08 |
Last modified on | 2021/03/06 |
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 |
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Condition | ||
Condition | sudden deafness | |
Classification by specialty |
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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 | |
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Interventions/Control_10 |
Eligibility | ||||
Age-lower limit |
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Age-upper limit |
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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 |
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Target sample size | 30 |
Research contact person | |||||||
Name of lead principal investigator |
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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 |
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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 | |
Institute | Iwate Medical University |
Institute | |
Department |
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 |
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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 | Enrolling by invitation | ||||||
Date of protocol fixation |
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Date of IRB |
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Anticipated trial start date |
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Last follow-up date |
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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 |
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Last modified on |
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Link to view the page | |
URL(English) | https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046419 |
Research Plan | |
Registered date | File name |
Research case data specifications | |
Registered date | File name |
Research case data | |
Registered date | File name |