UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000033010 |
|---|---|
| Receipt number | R000037633 |
| Scientific Title | Clinical significance of the perception on external auditory meatus evoked by portable peripheral nerve stimulator |
| Date of disclosure of the study information | 2018/08/01 |
| Last modified on | 2019/02/24 01:33:21 |
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Basic information
Public title
Clinical significance of the perception on external auditory meatus evoked by portable peripheral nerve stimulator
Acronym
Clinical significance of the perception on external auditory meatus evoked by portable peripheral nerve stimulator
Scientific Title
Clinical significance of the perception on external auditory meatus evoked by portable peripheral nerve stimulator
Scientific Title:Acronym
Clinical significance of the perception on external auditory meatus evoked by portable peripheral nerve stimulator
Region
| Japan |
Condition
Condition
sensorineural hearing loss, facial palsy, chronic otitis externa, and chronic otitis media
Classification by specialty
| Oto-rhino-laryngology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
evaluation of electrically evoked sensory threshold on external auditory meatus before and after treatment in each disease
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
electrically evoked sensory threshold on external auditory meatus three months after the treatment
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
Prevention
Type of intervention
| Device,equipment |
Interventions/Control_1
Before treatment, electrically evoked sensory threshold in external auditory meatus is measured using portable peripheral nerve stimulator. Three months (and 6 months, if possible) after the initial treatment, reexamination is performed in the same way.
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
those who were diagnosed sensorineural hearing loss, facial palsy, chronic otitis media, and chronic otitis externa in our hospital
Key exclusion criteria
those who are suffering from active otitis media, wet condition of external auditory canal due to inflammation, and external auditory canal stenosis
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Tetsuya Tono |
Organization
University of Miyazaki
Division name
Department of Otorhinolaryngology, Head and Neck Surgery, Faculty of Medicine
Zip code
Address
5200 kihara, kiyotake, miyazaki, miyazaki, 8891692, Japan
TEL
+81-985-85-2966
otorhino@med.miyazaki-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Takahiro Nakashima |
Organization
University of Miyazaki
Division name
Department of Otorhinolaryngology, Head and Neck Surgery, Faculty of Medicine
Zip code
Address
5200 kihara, kiyotake, miyazaki, miyazaki, 8891692, Japan
TEL
+81-985-85-2966
Homepage URL
otorhino@med.miyazaki-u.ac.jp
Sponsor or person
Institute
University of Miyazaki
Institute
Department
Personal name
Funding Source
Organization
Ministry of Education, Culture, Sports, Science and Technology
Organization
Division
Category of Funding Organization
Japanese Governmental office
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
| 2018 | Year | 08 | 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
Terminated
Date of protocol fixation
| 2018 | Year | 03 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2018 | Year | 08 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
| 2019 | Year | 03 | Month | 30 | Day |
Date trial data considered complete
Date analysis concluded
| 2019 | Year | 03 | Month | 30 | Day |
Other
Other related information
Management information
Registered date
| 2018 | Year | 06 | Month | 15 | Day |
Last modified on
| 2019 | Year | 02 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037633
