UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000041256 |
|---|---|
| Receipt number | 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 | 2022/05/18 09:44:36 |
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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
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
maruyama@artsci.kyushu-u.ac.jp
Sponsor or person
Institute
Department of Hematology, Oncology and Cardiovascular Medicine,
Kyushu University Hospital,
Fukuoka, Japan
Institute
Department
Personal name
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
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
Enrolling by invitation
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
| 2022 | Year | 05 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047111
