UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000041969 |
|---|---|
| Receipt number | R000042832 |
| Scientific Title | Effect of jelly on the benefit of cartilage conduction hearing aids |
| Date of disclosure of the study information | 2020/10/02 |
| Last modified on | 2022/04/07 08:34:59 |
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Basic information
Public title
Effect of jelly on the benefit of cartilage conduction hearing aids
Acronym
Effect of jelly on cartilage conduction hearing aids
Scientific Title
Effect of jelly on the benefit of cartilage conduction hearing aids
Scientific Title:Acronym
Effect of jelly on cartilage conduction hearing aids
Region
| Japan |
Condition
Condition
Cartilage conduction heaing aid user
Classification by specialty
| Oto-rhino-laryngology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The effects of echo jelly on the benefit of cartilage conduction hearing aids are evaluated. For instance, threshold improvement, and management of feedback problem
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
The threshold improvement, and management of feedback problem are measured.
Key secondary outcomes
None
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
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Jelly is put on the transducer.
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
| 3 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1 Cartilage conduction hearing aid user
2 Aural atresia or stenosis of the ear canal
3 The transducer is fixed without double-sided tape
Key exclusion criteria
None
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Tadashi |
| Middle name | |
| Last name | Nishimura |
Organization
Nara Medical University
Division name
Otolaryngology-head & neck surgery
Zip code
634-8522
Address
840 shijo-cho, Kashihara
TEL
0744223051
t-nishim@naramed-u.ac.jp
Public contact
Name of contact person
| 1st name | Tadashi |
| Middle name | |
| Last name | Nishimura |
Organization
Nara Medical University
Division name
Otolaryngology-head & neck surgery
Zip code
634-8522
Address
840 shijo-cho, Kashihara
TEL
0744223051
Homepage URL
t-nishim@naramed-u.ac.jp
Sponsor or person
Institute
Nara Medical University
Otolaryngology-head & neck surgery
Institute
Department
Personal name
Funding Source
Organization
Japan Society for the Promotion of Science
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Nara Medical University Ethics Committee
Address
840 shijo-cho, Kashihara
Tel
0744-22-3051
ino_rinri@naramed-u.ac.jp
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
奈良県立医科大学付属病院
Other administrative information
Date of disclosure of the study information
| 2020 | Year | 10 | Month | 02 | 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
23
Results
Results date posted
Results Delayed
| Delay expected |
Results Delay Reason
Under review
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
None
Outcome measures
Thresholds, Speech recognition score, Subjective evaluation
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
No longer recruiting
Date of protocol fixation
| 2019 | Year | 08 | Month | 01 | Day |
Date of IRB
| 2019 | Year | 09 | Month | 26 | Day |
Anticipated trial start date
| 2019 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2021 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2021 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2021 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2021 | Year | 03 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2020 | Year | 10 | Month | 01 | Day |
Last modified on
| 2022 | Year | 04 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042832
