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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000023597
Receipt No. R000027138
Scientific Title Evaluation of NISHIJIN ECG e-Textile
Date of disclosure of the study information 2016/08/31
Last modified on 2018/12/14

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Basic information
Public title Evaluation of NISHIJIN ECG e-Textile
Acronym Evaluation of NISHIJIN ECG e-Textile
Scientific Title Evaluation of NISHIJIN ECG e-Textile
Scientific Title:Acronym Evaluation of NISHIJIN ECG e-Textile
Region
Japan

Condition
Condition Cardiovascular Disease
Classification by specialty
Cardiology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To confirm the e-textile manufactured by NISHIJIN (Japanese traditional Brocade) Technique is equivalent to conventional ECG electrodes.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Explanatory
Developmental phase Not applicable

Assessment
Primary outcomes 1) Evaluation of obtained PQRS wave
2) Consistency of diagnosis given by automatic evaluaton functions of conventional ECG devices
3) Consistency of diagnosis given by cardiologists
Key secondary outcomes Subjective evaluation of easiness of wear

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 Measure ECG using new device
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

Not applicable
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria 10 healthy subjects and 10 patients of cardiovascular diseases who need to have frequent ECG measurement.
Key exclusion criteria 1) having any symptoms such as Eczema
2) Allergic on metal
3) A person who need agreement of representatives such as minority
4) Medical Doctors consider unsuitable
Target sample size 20

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Tomohiro Kuroda
Organization Kyoto University
Division name University Hospital
Zip code
Address Shogo-in Kawahara-cho 54, Kyoto, Japan
TEL 075-366-7701
Email tomo@kuhp.kyoto-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Tomohiro Kuroda
Organization Kyoto University
Division name University Hospital
Zip code
Address Shogo-in Kawahara-cho 54, Kyoto, Japan
TEL 075-366-7701
Homepage URL
Email tomo@kuhp.kyoto-u.ac.jp

Sponsor
Institute Kyoto University
Institute
Department

Funding Source
Organization self funding
Organization
Division
Category of Funding Organization Self funding
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
2016 Year 08 Month 31 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
2016 Year 08 Month 09 Day
Date of IRB
Anticipated trial start date
2016 Year 09 Month 30 Day
Last follow-up date
2018 Year 06 Month 27 Day
Date of closure to data entry
2018 Year 06 Month 27 Day
Date trial data considered complete
2018 Year 06 Month 27 Day
Date analysis concluded
2018 Year 06 Month 30 Day

Other
Other related information

Management information
Registered date
2016 Year 08 Month 12 Day
Last modified on
2018 Year 12 Month 14 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027138

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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