UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000044711 |
|---|---|
| Receipt number | R000051067 |
| Scientific Title | A Clinical Study to Evaluate the Efficacy and Safety of the Combined Use of an Ear Prosthesis and a Cartilage Conduction Hearing Aid for Patients with Auricular Defects |
| Date of disclosure of the study information | 2021/06/30 |
| Last modified on | 2023/01/05 15:20:54 |
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Basic information
Public title
Evaluation of the usefulness and safety of the combined use of an ear prosthesis and a cartilage conduction hearing aid
Acronym
Usefulness and safety of the combined use of an ear prosthesis and a cartilage hearing aid
Scientific Title
A Clinical Study to Evaluate the Efficacy and Safety of the Combined Use of an Ear Prosthesis and a Cartilage Conduction Hearing Aid for Patients with Auricular Defects
Scientific Title:Acronym
Evaluation of usefulness and safety of combined use of ear prosthesis and cartilage conduction hearing aids
Region
| Japan |
Condition
Condition
Patients with unilateral or bilateral auricular defects, including microtia who use the cartilage conduction hearing aid
Classification by specialty
| Oto-rhino-laryngology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Evaluate the efficacy and safety of the combined use of an ear prosthesis and a cartilage conduction hearing aid by assessing the effects on hearing, quality of life, and skin disorders.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
he effect on hearing function will be compared for each ear condition (without hearing aid, with cartilage conduction hearing aid only, or with cartilage conduction hearing aid and ear prosthesis).
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
NO
Dynamic allocation
NO
Institution consideration
Blocking
NO
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
Combined use of ear prosthesis who use the cartilage conduction hearing aid.
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
| 90 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Patients must be seen by the Department of Otolaryngology at Keio University by September 30, 2024, who wish to purchase a cartilage conduction hearing aid and who wish to receive this study device and meet all of the following criteria. (1) Patients between 5 and 90 years of age; (2) Patients with unilateral or bilateral auricular defects, including microtia; (3) Patients with at least aided or unaided hearing threshold of less than 40 dB on a trichotomous basis (mean of thresholds at 500, 1000, and 2000 Hz); (4) Patients who wish to purchase a cartilage conduction hearing aid on at least one side (5) Patients who understand the nature of the study and have provided written consent from the patient or caregiver.
Key exclusion criteria
(1) Patients who have allergic reactions to cartilage conduction hearing aids, ear prostheses, adhesive agents, skin protectants, or removers; (2) Patients who have difficulty in performing pure tone audiometry and speech intelligibility tests; (3) When the principal investigator or sub-investigator judges that participation in this study is not appropriate.
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Hiroyuki |
| Middle name | |
| Last name | Ozawa |
Organization
Keio University Hospital
Division name
Department of Otolaryngology-Head and Neck Surgery
Zip code
1608582
Address
Shinanomachi 35, Shinjuku, Tokyo
TEL
03-5363-3827
ent-group@keio.jp
Public contact
Name of contact person
| 1st name | Naoki |
| Middle name | |
| Last name | Oishi |
Organization
Keio University Hospital
Division name
Department of Otolaryngology-Head and Neck Surgery
Zip code
1608582
Address
Shinanomachi 35, Shinjuku, Tokyo
TEL
03-5363-3827
Homepage URL
ent-group@keio.jp
Sponsor or person
Institute
Keio University
Institute
Department
Personal name
Funding Source
Organization
Takeda Science Foundation
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Keio University
Address
Shinanomachi 35, Shinjuku, Tokyo
Tel
03-3353-1211
med-rinri-jimu@adst.keio.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
Other administrative information
Date of disclosure of the study information
| 2021 | Year | 06 | Month | 30 | 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
Open public recruiting
Date of protocol fixation
| 2021 | Year | 06 | Month | 15 | Day |
Date of IRB
| 2021 | Year | 06 | Month | 28 | Day |
Anticipated trial start date
| 2021 | Year | 09 | Month | 08 | Day |
Last follow-up date
| 2025 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2021 | Year | 06 | Month | 30 | Day |
Last modified on
| 2023 | Year | 01 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051067
