UMIN-CTR Clinical Trial

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	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
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000047111