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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000041969
Receipt No. R000042832
Scientific Title Effect of jelly on the benefit of cartilage conduction hearing aids
Date of disclosure of the study information 2020/10/02
Last modified on 2020/10/01

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Basic information
Public title Effect of jelly on the benefit of cartilage conduction hearing aids
Acronym Effect of jelly on cartilage conduction hearing aids
Scientific Title Effect of jelly on the benefit of cartilage conduction hearing aids
Scientific Title:Acronym Effect of jelly on cartilage conduction hearing aids
Region
Japan

Condition
Condition Cartilage conduction heaing aid user
Classification by specialty
Oto-rhino-laryngology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The effects of echo jelly on the benefit of cartilage conduction hearing aids are evaluated. For instance, threshold improvement, and management of feedback problem
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Explanatory
Developmental phase Not applicable

Assessment
Primary outcomes The threshold improvement, and management of feedback problem are measured.
Key secondary outcomes None

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Self control
Stratification NO
Dynamic allocation NO
Institution consideration Institution is not considered as adjustment factor.
Blocking NO
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Jelly is put on the transducer.
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
3 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria 1 Cartilage conduction hearing aid user
2 Aural atresia or stenosis of the ear canal
3 The transducer is fixed without double-sided tape
Key exclusion criteria None
Target sample size 30

Research contact person
Name of lead principal investigator
1st name Tadashi
Middle name
Last name Nishimura
Organization Nara Medical University
Division name Otolaryngology-head & neck surgery
Zip code 634-8522
Address 840 shijo-cho, Kashihara
TEL 0744223051
Email t-nishim@naramed-u.ac.jp

Public contact
Name of contact person
1st name Tadashi
Middle name
Last name Nishimura
Organization Nara Medical University
Division name Otolaryngology-head & neck surgery
Zip code 634-8522
Address 840 shijo-cho, Kashihara
TEL 0744223051
Homepage URL
Email t-nishim@naramed-u.ac.jp

Sponsor
Institute Nara Medical University
Otolaryngology-head & neck surgery
Institute
Department

Funding Source
Organization Japan Society for the Promotion of Science
Organization
Division
Category of Funding Organization Non profit foundation
Nationality of Funding Organization Japan

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization Nara Medical University Ethics Committee
Address 840 shijo-cho, Kashihara
Tel 0744-22-3051
Email icthaisin@naramed-u.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 奈良県立医科大学付属病院

Other administrative information
Date of disclosure of the study information
2020 Year 10 Month 02 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 Open public recruiting
Date of protocol fixation
2019 Year 08 Month 01 Day
Date of IRB
2019 Year 09 Month 26 Day
Anticipated trial start date
2019 Year 10 Month 01 Day
Last follow-up date
2021 Year 03 Month 31 Day
Date of closure to data entry
2021 Year 03 Month 31 Day
Date trial data considered complete
2021 Year 03 Month 31 Day
Date analysis concluded
2021 Year 03 Month 31 Day

Other
Other related information

Management information
Registered date
2020 Year 10 Month 01 Day
Last modified on
2020 Year 10 Month 01 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042832

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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