UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Assessment of cartilage conduction hearing aids
Title of the study (Brief title)	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	Tadashi Nishimura
Organization	Nara Medical University
Division name	Department of Otorhinolaryngology - Head and neck surgery
Address	840 shijo-cho, Kashihara
TEL	0744223051
Email	t-nishim@naramed-u.ac.jp

Public contact
Name of contact person	Tadashi Nishimura
Organization	Nara Medical University
Division name	Department of Otorhinolaryngology - Head and neck surgery
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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2013 Year 02 Month 01 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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/icdr_e/ctr_view.cgi?recptno=R000023173