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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000041256
Receipt No. R000047111
Scientific Title Pilot study of wireless vital monitoring using microwave reflectometry
Date of disclosure of the study information 2020/08/01
Last modified on 2020/07/30

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Basic information
Public title Pilot study of microwave reflectometry
Acronym Pilot study
Scientific Title Pilot study of wireless vital monitoring using microwave reflectometry
Scientific Title:Acronym Wireless vital monitoring
Region
Japan

Condition
Condition arrhythmia
Classification by specialty
Medicine in general Cardiology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Monitoring of heart beats and respiration has to tether the patients. Therefore, the main aim of this pilot study is to confirm the feasibility of our upgraded microwave reflectometry which enables non-contact monitring of vital signs under the clothing condition.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes Feasibility of monitoring vital signs by the microwave reflectometry.
Key secondary outcomes Diagnostic accuracy of arryhthmia detection by the microwave reflectometry.

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
90 years-old >
Gender Male and Female
Key inclusion criteria Case: Patients of arrhythmias (heart rhythm irregularity) which are under treatment or follow-up.
Control: Subjects free from arrhythmias
Key exclusion criteria Subjects showing dementia or noncooperation.
Subjects judged to be inadequate.
Target sample size 20

Research contact person
Name of lead principal investigator
1st name Toru
Middle name
Last name Maruyama
Organization Kyushu University
Division name Department of Medicine
Zip code 812-8586
Address Maidashi 3-1-1, Higashi-ku, Fukuoka, Japan
TEL 81926425235
Email maruyama@artsci.kyushu-u.ac.jp

Public contact
Name of contact person
1st name Toru
Middle name
Last name Maruyama
Organization Kyushu Univerdity
Division name Department of Medicine
Zip code 812-8586
Address Maidashi 3-1-1, Higashi-ku, Fukuoka, Japan
TEL 81926425235
Homepage URL
Email maruyama@artsci.kyushu-u.ac.jp

Sponsor
Institute Department of Hematology, Oncology and Cardiovascular Medicine,
Kyushu University Hospital,
Fukuoka, Japan
Institute
Department

Funding Source
Organization Mitsui Sumitomo Insurance Welfare Foundation
Organization
Division
Category of Funding Organization Non profit foundation
Nationality of Funding Organization JPN

Other related organizations
Co-sponsor Global Innovation Center, Kyushu Univerity
Name of secondary funder(s)

IRB Contact (For public release)
Organization Advanced Research Oganization (ARO), Kyushu University Hospital
Address Maidashi 3-1-1, Higashi-ku, Fukuoka, Japan
Tel 81926425774
Email http://www.med.kyushu-u.ac.jp/crc/

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 九州大学病院(福岡県)

Other administrative information
Date of disclosure of the study information
2020 Year 08 Month 01 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 Preinitiation
Date of protocol fixation
2020 Year 04 Month 01 Day
Date of IRB
2020 Year 08 Month 30 Day
Anticipated trial start date
2020 Year 10 Month 01 Day
Last follow-up date
2022 Year 03 Month 31 Day
Date of closure to data entry
2022 Year 04 Month 01 Day
Date trial data considered complete
2022 Year 04 Month 30 Day
Date analysis concluded
2022 Year 08 Month 30 Day

Other
Other related information Observational study to compare the heart beat rhythm in cases of arrhythmias with that in controls.

Management information
Registered date
2020 Year 07 Month 30 Day
Last modified on
2020 Year 07 Month 30 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047111

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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