NIPH Clinical Trials Search

JAPANESE
国立保健医療科学院
JRCT ID: jRCTs032190002

Registered date:02/04/2019

VSB for unilateral conductive or mixed hearing loss

Basic Information

Recruitment status Complete
Health condition(s) or Problem(s) studiedUnilateral conductive hearing loss or Mixed hearing loss
Date of first enrollment24/08/2018
Target sample size5
Countries of recruitmentJapan
Study typeInterventional
Intervention(s)Set the flowing mass transducer of VSB system on the round window by operation.

Outcome(s)

Primary OutcomeThe therapeutic effects are evaluated at 12 month after VSB surgery using free field audiometry. 20dB or more threshold recovery regarded as effective cases.
Secondary OutcomeInner and after surgery safeness and adverse event in the observation period.

Key inclusion & exclusion criteria

Age minimum>= 4age old
Age maximumNot applicable
GenderBoth
Include criteriaGeneral inclusion criteria 1)Written informed consent was obtained from patient (or their guardians if they are minor). 2)The age of informed consent was 4 years old or above. Audiometric inclusion criteria 1)Unilateral conductive hearing loss or mixed hearing loss. 2)Patient fulfill the below bone conduction hearing thresholds. 500Hz:45dB or less 1000Hz:50dB or less 2000Hz:65dB or less 4000Hz:65dB or less
Exclude criteria1) Patients with highly malformation of cochlear or temporal bones. 2) Patients do not use general anesthesia.

Related Information

Contact

Public contact
Name Hiroaki Suzuki
Address 3-1-1 Asahi, Matsumoto Nagano Nagano Japan 390-8621
Telephone +81-263-37-2666
E-mail youu@shinshu-u.ac.jp
Affiliation Shinshu University Hospital
Scientific contact
Name Hiroaki Suzuki
Address 3-1-1 Asahi, Matsumoto Nagano Nagano Japan 390-8621
Telephone +81-263-37-2666
E-mail youu@shinshu-u.ac.jp
Affiliation Shinshu University Hospital