Unique ID issued by UMIN | UMIN000005867 |
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Receipt number | R000006932 |
Scientific Title | Clinical research of low invasion cochlea implant electrode. |
Date of disclosure of the study information | 2011/06/28 |
Last modified on | 2022/12/06 12:35:35 |
Clinical research of low invasion cochlea implant electrode.
Clinical research of low invasion cochlea implant.
Clinical research of low invasion cochlea implant electrode.
Clinical research of low invasion cochlea implant.
Japan |
Bilateral profound sensorineural hearing loss
Oto-rhino-laryngology |
Others
NO
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.
Safety,Efficacy
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
Interventional
Single arm
Non-randomized
Open -no one is blinded
Historical
1
Treatment
Device,equipment |
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.
2 | years-old | <= |
Not applicable |
Male and Female
Bilateral profound sensorineural hearing loss.
Acute progressive hearing loss.
Conductive hearing loss.
5
1st name | |
Middle name | |
Last name | Shin-ichi Usami |
Shinshu University School of Medicine
Department of Otorhinolaryngology
3-1-1 Asahi, Matsumoto, Nagano, JAPAN
1st name | |
Middle name | |
Last name |
Shinshu University School of Medicine
Department of Otorhinolaryngology
3-1-1 Asahi, Matsumoto, Nagano, JAPAN
Shinshu University Hospital
None
Other
NO
2011 | Year | 06 | Month | 28 | Day |
Unpublished
Completed
2011 | Year | 04 | Month | 20 | Day |
2011 | Year | 03 | Month | 08 | Day |
2011 | Year | 06 | Month | 01 | Day |
2016 | Year | 03 | Month | 01 | Day |
2011 | Year | 06 | Month | 28 | Day |
2022 | Year | 12 | Month | 06 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006932
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