UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000005153 |
|---|---|
| Receipt number | R000006120 |
| Scientific Title | Middle ear implantation surgery |
| Date of disclosure of the study information | 2011/04/01 |
| Last modified on | 2011/02/28 19:25:54 |
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Basic information
Public title
Middle ear implantation surgery
Acronym
Middle ear implantation surgery
Scientific Title
Middle ear implantation surgery
Scientific Title:Acronym
Middle ear implantation surgery
Region
| Japan |
Condition
Condition
Conductive hearing loss and 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 medical treatment using hearing aid or cochlea implantation are important to get out from this situations. A middle ear implant system will improve the hearing and communication ability of mixed hearing loss patients who cannot use hearing aids for medical reasons or who are dissatisfied with other hearing devices. A middle ear implant system has already used clinicaly in Europe and already confirmed the venefit of this system for European population. In this clinical research, we confirm the middle ear implant system venefit in Japanese mixed hearing loss patients who cannot use hearing aids for medical reasons or who are dissatisfied with other hearing devices and also confirm the safetiness of the middle ear implant system in Japanese.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The therapeutic effects are evaluated at 5 month after the middle ear implantation surgery, using the free field speech recognition threshold test.
In the speech recognition threshold test with quiet, marked recovery is defined as any recovery of the maximum speech recognition score (%) by speech recognition threshold test using 67S or 57S Japanese monosyyrable word table (Japan Audiological Society 1967, 1957).
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
The middle ear implant is performed under general anesthesia. The antromastoidectomy is performed, followed by an atticotomy and posterior tympanotomy and the floating mass transducer (oscillator) is placed on the round window. The internal receiver is sutured to the skull and the skin is closed.
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
| 20 | years-old | <= |
Age-upper limit
| 74 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Adult conductive hearing loss and mixed hearing loss with exteranal or middle ear disease patients.
1) Remaining hearing loss despite of the tympanoplasty or stapes surgery has done, and listening the conversation is insufficiency by air conductive HA. Or inflammation of middle ear and external canal get worth due to using HA.
2) External ear malfomation with conductive hearing loss and mixed hearing loss, who cannot use conventional hearing aids or who are unsatisfied with them and do not achieve sufficient benefit.
Corresponding to the bone conduction hearing frequencies listed as follows
1) 500Hz is under 45dB
2) 1000Hz is under 50dB
3) 2000Hz and 4000Hz are under 65dB
Key exclusion criteria
The exclusion criteria are as follows:
(1) Retrolabyrinthine deafness, central deafness
(2) Active stage of refractory otitis media
(3) Acute progressive sensorineural hearing loss
(4) Inner ear disorder becaouse of labyrinthitis in adulthood
(5) Chronic or refractory vestibular disfunction
Target sample size
1
Research contact person
Name of lead principal investigator
| 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 Ashahi, Matsumoto, Nagano, JAPAN
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Satoshi Iwasaki |
Organization
Shinshu University school of Medicine
Division name
Department of Otorhinolaryngology
Zip code
Address
TEL
Homepage URL
Sponsor or person
Institute
Shinshu University hospital
Institute
Department
Personal name
Funding Source
Organization
none
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
MED-EL Electro-Medizinische Gerate GMBH
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
| 2011 | Year | 04 | Month | 01 | 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
Enrolling by invitation
Date of protocol fixation
| 2011 | Year | 02 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2011 | Year | 04 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2011 | Year | 02 | Month | 28 | Day |
Last modified on
| 2011 | Year | 02 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006120
