UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000016634 |
|---|---|
| Receipt number | R000019311 |
| Scientific Title | Clinical evaluation of bone-conduction hearing implant/titanium prosthesis in conductive/mixed hearing loss |
| Date of disclosure of the study information | 2015/02/25 |
| Last modified on | 2017/11/06 13:38:37 |
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Basic information
Public title
Clinical evaluation of bone-conduction hearing implant/titanium prosthesis in conductive/mixed hearing loss
Acronym
Clinical evaluation of bone-conduction hearing implant/titanium prosthesis in conductive/mixed hearing loss
Scientific Title
Clinical evaluation of bone-conduction hearing implant/titanium prosthesis in conductive/mixed hearing loss
Scientific Title:Acronym
Clinical evaluation of bone-conduction hearing implant/titanium prosthesis in conductive/mixed hearing loss
Region
| Japan |
Condition
Condition
Hearing loss due to middle ear anomalies and other conditions in which conventional tympanoplasty is not effective
Classification by specialty
| Oto-rhino-laryngology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to evaluate the efficacy and safety of implantable bone-conduction device or titanium prosthesis in conductive or mixed hearing loss.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
adverse events and hearing outcome
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
Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
device: bone-conduction hearing implant or titanium ossicular prosthesis
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
those who were diagnosed ear malformations or other diseases in which tympanoplasty supposed not to be effective
Key exclusion criteria
active otits media
Target sample size
4
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Tetsuya Tono |
Organization
University of Miyazaki
Division name
Department of Otolaryngology, Head and Neck Surgery
Zip code
Address
kihara 5200, kiyotake-cho, miyazaki, miyazaki, 889-1692, Japan
TEL
0985-85-2966
tono@med.miyazaki-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Takahiro Nakashima |
Organization
University of Miyazaki
Division name
Department of Otolaryngology, Head and Neck Surgery
Zip code
Address
kihara 5200, kiyotake-cho, miyazaki, miyazaki, 889-1692, Japan
TEL
0985-85-2966
Homepage URL
takahiro_nakashima@med.miyazaki-u.ac.jp
Sponsor or person
Institute
University of Miyazaki
Institute
Department
Personal name
Funding Source
Organization
University of Miyazaki
Organization
Division
Category of Funding Organization
Other
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
| 2015 | Year | 02 | Month | 25 | 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
| 2015 | Year | 02 | Month | 23 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 02 | Month | 25 | Day |
Last follow-up date
Date of closure to data entry
| 2017 | Year | 11 | Month | 06 | Day |
Date trial data considered complete
Date analysis concluded
| 2017 | Year | 06 | Month | 30 | Day |
Other
Other related information
Management information
Registered date
| 2015 | Year | 02 | Month | 25 | Day |
Last modified on
| 2017 | Year | 11 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019311
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
