UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000020060 |
|---|---|
| Receipt number | R000023173 |
| Scientific Title | Assessment of cartilage conduction hearing aids |
| Date of disclosure of the study information | 2015/12/16 |
| Last modified on | 2018/06/05 11:02:28 |
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Basic information
Public title
Assessment of cartilage conduction hearing aids
Acronym
cartilage conduction hearing aids
Scientific Title
Assessment of cartilage conduction hearing aids
Scientific Title:Acronym
cartilage conduction hearing aids
Region
| Japan |
Condition
Condition
hearing-impaired person
Classification by specialty
| Oto-rhino-laryngology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Evaluation of cartilage conduction hearing aids
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Others
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
The effectiveness is measured by audiometric test. After daily life use, the effectiveness and safety are evaluated using a questionnaire. The assessments are carried out every 1-6 month.
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
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
Developed cartilage conduction hearing aids are fitting, and used in daily life. It is continued until it is approved or until the participates do not want to use it.
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
| 2 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Aural atresia, The hearing impaired persons who are not satisfied with exsiting hearing aids
Key exclusion criteria
not appliocalbe
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Tadashi Nishimura |
Organization
Nara Medical University
Division name
Department of Otorhinolaryngology - Head and neck surgery
Zip code
Address
840 shijo-cho, Kashihara
TEL
0744223051
t-nishim@naramed-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Tadashi Nishimura |
Organization
Nara Medical University
Division name
Department of Otorhinolaryngology - Head and neck surgery
Zip code
Address
840 shijo-cho, Kashihara
TEL
0744223051
Homepage URL
t-nishim@naramed-u.ac.jp
Sponsor or person
Institute
Nara Medical University
Institute
Department
Personal name
Funding Source
Organization
Rion CO.,Ltd
Organization
Division
Category of Funding Organization
Other
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
| 2015 | Year | 12 | Month | 16 | 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
Completed
Date of protocol fixation
| 2013 | Year | 02 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 02 | Month | 01 | Day |
Last follow-up date
| 2018 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2018 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2018 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2019 | Year | 03 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2015 | Year | 12 | Month | 03 | Day |
Last modified on
| 2018 | Year | 06 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023173
