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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000005867
Receipt No. R000006932
Scientific Title Clinical research of low invasion cochlea implant electrode.
Date of disclosure of the study information 2011/06/28
Last modified on 2011/06/28

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Basic information
Public title Clinical research of low invasion cochlea implant electrode.
Acronym Clinical research of low invasion cochlea implant.
Scientific Title Clinical research of low invasion cochlea implant electrode.
Scientific Title:Acronym Clinical research of low invasion cochlea implant.
Region
Japan

Condition
Condition Bilateral profound sensorineural hearing loss
Classification by specialty
Oto-rhino-laryngology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Hearing loss causes serious disability of smooth communication, so the medical treatment using hearing aid or cochlea implantation are important.
Through this clinical research, we investigate the safety and efficiency of low invasion type of cochlea implant.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes The therapeutic effects are evaluated at 6 month after the cochlea implant operation using free field audiometry. In free field audiometry test, marked recovery is defined as more than 40dB HL recovery in the mean hearing level of 500Hz, 1000Hz, 2000Hz
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 Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Device,equipment
Interventions/Control_1 The cochlea implantation is performed under general anesthesia. Same as standard cochlea implant surgeries, an antromastoidectomy is performed, followed by an atticotomy and posteriot tympanotomy and insert cochlea implant electrode to cochlea and fix implanted electrode and signal receiver from speech processor.
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 Bilateral profound sensorineural hearing loss.
Key exclusion criteria Acute progressive hearing loss.
Conductive hearing loss.
Target sample size 5

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Shin-ichi Usami
Organization Shinshu University School of Medicine
Division name Department of Otorhinolaryngology
Zip code
Address 3-1-1 Asahi, Matsumoto, Nagano, JAPAN
TEL
Email

Public contact
Name of contact person
1st name
Middle name
Last name
Organization Shinshu University School of Medicine
Division name Department of Otorhinolaryngology
Zip code
Address 3-1-1 Asahi, Matsumoto, Nagano, JAPAN
TEL
Homepage URL
Email

Sponsor
Institute Shinshu University Hospital
Institute
Department

Funding Source
Organization None
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
2011 Year 06 Month 28 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
2011 Year 04 Month 20 Day
Date of IRB
Anticipated trial start date
2011 Year 06 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2011 Year 06 Month 28 Day
Last modified on
2011 Year 06 Month 28 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006932

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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