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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000033360
Receipt No. R000038032
Official scientific title of the study Clinical research of the bone conductive hearing system.
Date of disclosure of the study information 2018/07/11
Last modified on 2018/07/11

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Basic information
Official scientific title of the study Clinical research of the bone conductive hearing system.
Title of the study (Brief title) Bone conductive hearing system
Region
Japan

Condition
Condition conductive hearing loss.
mixed 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 appropriate medical treatment is important to get out from this situation. Conductive hearing loss was usually treated by fitting hearing aid or ossicular reconstruction surgely but in some case, the improvement of hearing ability was not sufficient for smooth communication. The bone conductive hearing implantation will improve the hearing ability and communication ability of bone conductive hearing loss patients. In this clinical research, we confirm the BONEBRIDGE system benefit in Japanese conductive hearing loss patients.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes The therapeutic effects are evaluated at 12 month after the BONEBRIDGE operation, using free field audiometry. In this test, marked recovery is defined as 20dB or more recovery in the mean hearing level at the 500, 1000 2000 and 4000Hz
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 Self control
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 bone conductive hearing implantation is performed under general anesthesia. For the bone conductive implantation, a bed for FMT (Floating
Mass Transducer) is drilled in the sinodural angle and fixed with two cortical screws. The receiver coil of
the BCI is placed on the bone under the periosteum. The implant system can be activated, after the
swelling of the skin flap above the implant has reduced.
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
5 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Conductive or mixed hearing loss patients with residual bone conduction thresholds in 500Hz to 4000Hz under 45 dB.
Key exclusion criteria The patients with severe bone malformation and did not have enough setting space for bone conductive implantation.
Patient who did not perform general anesthesia.
Target sample size 5

Research contact person
Name of lead principal investigator Hiroaki Suzuki
Organization Shinshu University School of Medicine
Division name Department of Otorhinolaryngology
Address 3-1-1 Asahi, Matsumoto, Nagano, JAPAN
TEL 0263-37-2666
Email nishio@shinshu-u.ac.jp

Public contact
Name of contact person Shin-ichi Usami
Organization Shinshu University School of Medicine
Division name Department of Otorhinolaryngology
Address 3-1-1 Asahi, Matsumoto, Nagano, JAPAN
TEL 0263-37-2666
Homepage URL
Email usami@shinshu-u.ac.jp

Sponsor
Institute Shinshu University School of Medicine
Institute
Department

Funding Source
Organization none
Organization
Division
Category of Funding Organization Self funding
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
2018 Year 07 Month 11 Day

Progress
Recruitment status Open public recruiting
Date of protocol fixation
2018 Year 06 Month 21 Day
Anticipated trial start date
2018 Year 07 Month 06 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results Unpublished
URL releasing results
Results
Other related information

Management information
Registered date
2018 Year 07 Month 11 Day
Last modified on
2018 Year 07 Month 11 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038032

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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