UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000027634
Receipt number R000031660
Scientific Title A feasibility study on whether a stethoscope sensor using a sheet type biosensor can record heart murmur and heart sound
Date of disclosure of the study information 2017/06/04
Last modified on 2020/03/19 16:24:59

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Basic information

Public title

A feasibility study on whether a stethoscope sensor using a sheet type biosensor can record heart murmur and heart sound

Acronym

A feasibility study on whether a stethoscope sensor using a sheet type biosensor can record heart murmur and heart sound

Scientific Title

A feasibility study on whether a stethoscope sensor using a sheet type biosensor can record heart murmur and heart sound

Scientific Title:Acronym

A feasibility study on whether a stethoscope sensor using a sheet type biosensor can record heart murmur and heart sound

Region

Japan


Condition

Condition

hospitalized patient and outpatient

Classification by specialty

Cardiology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

Evaluate whether the auscultation sensor can appropriately record vibrations such as heart murmurs and heart sounds

Basic objectives2

Others

Basic objectives -Others

feasibility study

Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Evaluate whether the auscultation sensor can appropriately record vibrations such as heart murmurs and heart sounds

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

Uncontrolled

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

1

Purpose of intervention

Diagnosis

Type of intervention

Device,equipment

Interventions/Control_1

a stethoscope sensor

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

16 years-old <=

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

Patient who got written consent

Key exclusion criteria

Patients that researchers deemed inappropriate as subjects

Target sample size

200


Research contact person

Name of lead principal investigator

1st name Tomoyuki
Middle name
Last name Umemoto

Organization

Tokyo Medical and Dental University

Division name

Department of Cardiovascular Medicine

Zip code

113-8510

Address

1-5-45, Yushima, Bunkyo-ku, Tokyo, 113-8519

TEL

03-5803-5231

Email

umemoto.cvm@tmd.ac.jp


Public contact

Name of contact person

1st name Tomoyuki
Middle name
Last name Umemoto

Organization

Tokyo Medical and Dental University

Division name

Department of Cardiovascular Medicine

Zip code

113-8510

Address

1-5-45, Yushima, Bunkyo-ku, Tokyo, 113-8519

TEL

03-5803-5231

Homepage URL


Email

umemoto.cvm@tmd.ac.jp


Sponsor or person

Institute

Tokyo Medical and Dental University

Institute

Department

Personal name



Funding Source

Organization

Yamaha Corporation

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

Medical Research Ethics Committee of Tokyo Medical and Dental University

Address

1-5-45, Yushima, Bunkyo-ku, Tokyo, 113-8519

Tel

03-5803-5096

Email

info.bec@tmd.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

2017 Year 06 Month 04 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

Enrolling by invitation

Date of protocol fixation

2017 Year 06 Month 29 Day

Date of IRB

2017 Year 06 Month 29 Day

Anticipated trial start date

2017 Year 10 Month 01 Day

Last follow-up date

2021 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

2017 Year 06 Month 04 Day

Last modified on

2020 Year 03 Month 19 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031660


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name