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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000020060
Receipt No. 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

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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
Email 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
Email t-nishim@naramed-u.ac.jp

Sponsor
Institute Nara Medical University
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023173

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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