UMIN-CTR Clinical Trial

Basic information
Public title	Clinical research of the bone conductive hearing system.
Acronym	Bone conductive hearing system
Scientific Title	Clinical research of the bone conductive hearing system.
Scientific Title:Acronym	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	1st name Middle name Last name Hiroaki Suzuki
Organization	Shinshu University School of Medicine
Division name	Department of Otorhinolaryngology
Zip code
Address	3-1-1 Asahi, Matsumoto, Nagano, JAPAN
TEL	0263-37-2666
Email	nishio@shinshu-u.ac.jp

Public contact
Name of contact person	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	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)

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	2018 Year 07 Month 11 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	Completed
Date of protocol fixation	2018 Year 06 Month 21 Day
Date of IRB	2016 Year 08 Month 16 Day
Anticipated trial start date	2018 Year 07 Month 06 Day
Last follow-up date	2021 Year 06 Month 03 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2018 Year 07 Month 11 Day
Last modified on	2022 Year 12 Month 06 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038032