UMIN ID: UMIN000030055
Registered date:21/11/2017
VSB for unilateral conductive or mixed hearing loss
Basic Information
| Recruitment status | Complete: follow-up complete |
|---|---|
| Health condition(s) or Problem(s) studied | Unilateral conductive hearing loss Unilateral mixed hearing loss |
| Date of first enrollment | 2016/07/09 |
| Target sample size | 5 |
| Countries of recruitment | Japan |
| Study type | Interventional |
| Intervention(s) | Set the flowing mass transducer of VSB system on the round window by operation. |
Outcome(s)
| Primary Outcome | The therapeutic effects are evaluated at 12 month after VSB surgely using free field audiometoly. 20dB or more threshold recovery regarded as effective cases. |
|---|---|
| Secondary Outcome |
Key inclusion & exclusion criteria
| Age minimum | 4years-old |
|---|---|
| Age maximum | Not applicable |
| Gender | Male and Female |
| Include criteria | |
| Exclude criteria | 1) Patients with highly malformation of cochlear or temporal bones. 2) Patients do not use general anesthesia. |
Related Information
| Primary Sponsor | Shinshu University School of Medicine |
|---|---|
| Secondary Sponsor | International University of Health and Welfar, Mita Hospital |
| Source(s) of Monetary Support | Shinshu University Hospital |
| Secondary ID(s) |
Contact
| public contact | |
| Name | Shin-ya Nishio |
| Address | 3-1-1 Asahi Matsumoto Japan |
| Telephone | 0263-37-2666 |
| nishio@shinshu-u.ac.jp | |
| Affiliation | Shinshu University School of Medicine Department of Otorhinolaryngology |
| scientific contact | |
| Name | Hiroaki Suzuki |
| Address | 3-1-1 Asahi Matsumoto Japan |
| Telephone | 0263-37-2666 |
| nishio@shinshu-u.ac.jp | |
| Affiliation | Shinshu University School of Medicine Department of Otorhinolaryngology |