UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000023597 |
|---|---|
| Receipt number | 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 15:04:01 |
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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
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
tomo@kuhp.kyoto-u.ac.jp
Sponsor or person
Institute
Kyoto University
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027138
