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

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 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

Email

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


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name