UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000039569 |
|---|---|
| Receipt number | R000045127 |
| Scientific Title | Evaluation of the facial nerve and the chorda tympani using ultra-high resolution CT |
| Date of disclosure of the study information | 2020/04/01 |
| Last modified on | 2021/03/06 13:35:34 |
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Basic information
Public title
Evaluation of the facial nerve and the chorda tympani using ultra-high resolution CT
Acronym
Evaluation of the facial nerve and chorda tympani with UHRCT
Scientific Title
Evaluation of the facial nerve and the chorda tympani using ultra-high resolution CT
Scientific Title:Acronym
Evaluation of the facial nerve and chorda tympani with UHRCT
Region
| Japan |
Condition
Condition
Conductive hearing loss with normal tympanic membrane
Classification by specialty
| Oto-rhino-laryngology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To see the relationship between the ossicles and the facial nerve / chorda tympani using ultra-high resolution CT
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Compare the intra-operative findings and the CT findings, to calculate the sensitivity of the adhesion of ossicles and the facial nerve / chorda tympani
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
| 6 | years-old | <= |
Age-upper limit
| 90 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1) Scheduled to receive tympanoplasty or stapes surgery at Iwate Medical University
2) Older than 6 years at the time of undergoing UHRCT
3) With normal tympanic membrane
4) No abnormal tissue in the middle ear
5) With informed consent to this study with documents
Key exclusion criteria
1) Without consent to this study
2) Younger than 6 years at the time of undergoing UHRCT
3) With abnormal tympanic membrane
4) With abnormal tissue in the middle ear
5) Those who are judged to be inadequate by the researchers
Target sample size
25
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
019-613-7111
hhiraumi@iwate-med.ac.jp
Public contact
Name of contact person
| 1st name | Fumie |
| Middle name | |
| Last name | Kanezaki |
Organization
Iwate Medical University
Division name
Otolaryngology
Zip code
028-3695
Address
2-1-1, Idai doori, Yahaba City, Shiwa, Iwate, Japan
TEL
019-613-7111
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
Iwate Medical University
Tel
+81196137111
hhiraumi@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
Other administrative information
Date of disclosure of the study information
| 2020 | Year | 04 | Month | 01 | 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
Enrolling by invitation
Date of protocol fixation
| 2020 | Year | 04 | Month | 01 | Day |
Date of IRB
| 2020 | Year | 06 | Month | 22 | Day |
Anticipated trial start date
| 2020 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2023 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2023 | Year | 04 | Month | 30 | Day |
Date trial data considered complete
Date analysis concluded
Other
Other related information
Compare the relationship between the ossicles and the facial nerve/chorda tympani obtained intraoperatibvely and using ultra-high resolution CT
Management information
Registered date
| 2020 | Year | 02 | Month | 22 | Day |
Last modified on
| 2021 | Year | 03 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045127
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
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| Registered date | File name |
