UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000016634
Receipt number R000019311
Scientific Title Clinical evaluation of bone-conduction hearing implant/titanium prosthesis in conductive/mixed hearing loss
Date of disclosure of the study information 2015/02/25
Last modified on 2017/11/06 13:38:37

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Basic information

Public title

Clinical evaluation of bone-conduction hearing implant/titanium prosthesis in conductive/mixed hearing loss

Acronym

Clinical evaluation of bone-conduction hearing implant/titanium prosthesis in conductive/mixed hearing loss

Scientific Title

Clinical evaluation of bone-conduction hearing implant/titanium prosthesis in conductive/mixed hearing loss

Scientific Title:Acronym

Clinical evaluation of bone-conduction hearing implant/titanium prosthesis in conductive/mixed hearing loss

Region

Japan


Condition

Condition

Hearing loss due to middle ear anomalies and other conditions in which conventional tympanoplasty is not effective

Classification by specialty

Oto-rhino-laryngology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

The purpose of this study is to evaluate the efficacy and safety of implantable bone-conduction device or titanium prosthesis in conductive or mixed hearing loss.

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1

Confirmatory

Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

adverse events and hearing outcome

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

device: bone-conduction hearing implant or titanium ossicular prosthesis

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

18 years-old <=

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

those who were diagnosed ear malformations or other diseases in which tympanoplasty supposed not to be effective

Key exclusion criteria

active otits media

Target sample size

4


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Tetsuya Tono

Organization

University of Miyazaki

Division name

Department of Otolaryngology, Head and Neck Surgery

Zip code


Address

kihara 5200, kiyotake-cho, miyazaki, miyazaki, 889-1692, Japan

TEL

0985-85-2966

Email

tono@med.miyazaki-u.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Takahiro Nakashima

Organization

University of Miyazaki

Division name

Department of Otolaryngology, Head and Neck Surgery

Zip code


Address

kihara 5200, kiyotake-cho, miyazaki, miyazaki, 889-1692, Japan

TEL

0985-85-2966

Homepage URL


Email

takahiro_nakashima@med.miyazaki-u.ac.jp


Sponsor or person

Institute

University of Miyazaki

Institute

Department

Personal name



Funding Source

Organization

University of Miyazaki

Organization

Division

Category of Funding Organization

Other

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization


Address


Tel


Email



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

2015 Year 02 Month 25 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

Completed

Date of protocol fixation

2015 Year 02 Month 23 Day

Date of IRB


Anticipated trial start date

2015 Year 02 Month 25 Day

Last follow-up date


Date of closure to data entry

2017 Year 11 Month 06 Day

Date trial data considered complete


Date analysis concluded

2017 Year 06 Month 30 Day


Other

Other related information



Management information

Registered date

2015 Year 02 Month 25 Day

Last modified on

2017 Year 11 Month 06 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019311


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name