UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000035512
Receipt number R000039024
Scientific Title Development of ossicular mobility device using artificail intelligence
Date of disclosure of the study information 2019/01/11
Last modified on 2021/04/17 03:12:36

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Basic information

Public title

Development of ossicular mobility device using artificail intelligence

Acronym

ossicular mobility device

Scientific Title

Development of ossicular mobility device using artificail intelligence

Scientific Title:Acronym

ossicular mobility device

Region

Japan


Condition

Condition

conductive mixed hearing loss

Classification by specialty

Oto-rhino-laryngology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

The low mobility of the ossicules affects sound transmission efficiency.We find out how measurement of mobility during surgery affects postoperative hearing.

Basic objectives2

Others

Basic objectives -Others

Collecting hearing or audiological data at pre- and at post-operation and operative finings from previosly operated surgery(tympanoplasty,stapedectomy and stapedotomy) which we have not measured ossicular mobility.

Trial characteristics_1

Exploratory

Trial characteristics_2

Pragmatic

Developmental phase

Not applicable


Assessment

Primary outcomes

hearing before and after surgery

Key secondary outcomes



Base

Study type

Observational


Study design

Basic design


Randomization


Randomization unit


Blinding


Control


Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms


Purpose of intervention


Type of intervention


Interventions/Control_1


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

20 years-old <=

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

conductive or mixed hearing loss (middle ear disease )

Key exclusion criteria

less than 20 years old

Target sample size

400


Research contact person

Name of lead principal investigator

1st name Sho
Middle name
Last name Kanzaki

Organization

Keio University School of medicine

Division name

Dept. Otolaryngology

Zip code

160-8586

Address

35 Shinanomachi Shinjuku Tokyo

TEL

+81353633827

Email

skan@a7.keio.jp


Public contact

Name of contact person

1st name Sho
Middle name
Last name Kanzaki

Organization

Keio University School of medicine

Division name

Otolaryngology

Zip code

160-8582

Address

35 Shinanomachi Shinjuku Tokyo

TEL

0353633827

Homepage URL


Email

skan@keio.jp


Sponsor or person

Institute

Keio University School of Medicine

Institute

Department

Personal name



Funding Source

Organization

Ministry of Economy, Trade and Industry

Organization

Division

Category of Funding Organization

Japanese Governmental office

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

Keio University

Address

35 Shinanomachi shinjuku Tokyo

Tel

+81353633827

Email

skan@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

2019 Year 01 Month 11 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

2018 Year 09 Month 21 Day

Date of IRB

2018 Year 09 Month 26 Day

Anticipated trial start date

2019 Year 01 Month 11 Day

Last follow-up date

2023 Year 04 Month 30 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

ossicles mobility during surgery and differences between pre and post hearing, etc.


Management information

Registered date

2019 Year 01 Month 11 Day

Last modified on

2021 Year 04 Month 17 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039024


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name