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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000044711
Receipt No. 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 2021/09/09

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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
Dynamic allocation
Institution consideration
Blocking
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
Email 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
Email ent-group@keio.jp

Sponsor
Institute Keio University
Institute
Department

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
Email ent-group@keio.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
2021 Year 09 Month 09 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051067

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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