UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000033360 |
|---|---|
| Receipt number | R000038032 |
| Scientific Title | Clinical research of the bone conductive hearing system. |
| Date of disclosure of the study information | 2018/07/11 |
| Last modified on | 2022/12/06 12:30:26 |
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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
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
usami@shinshu-u.ac.jp
Sponsor or person
Institute
Shinshu University School of Medicine
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038032
