UMIN-CTR Clinical Trial

Basic information
Public title	On-site verification and patient impact investigation of cross check system using ultra high frequency RFID tag and RFID reader
Acronym	On-site verification and patient impact investigation of cross check system using ultra high frequency RFID tag and RFID reader
Scientific Title	On-site verification and patient impact investigation of cross check system using ultra high frequency RFID tag and RFID reader
Scientific Title:Acronym	On-site verification and patient impact investigation of cross check system using ultra high frequency RFID tag and RFID reader
Region	Japan

Condition
Condition	Patient with implantable cardiac device
Classification by specialty	Not applicable
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	We will prove that 920MHz range handy-type RFID reader (low output type: 250mW) do not affect the implantable cardiac device.
Basic objectives2	Safety
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	existence or non-existence of unanticipated setting change of implantable cardiac device
Key secondary outcomes	existence or non-existence of nursing work alleviation

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Uncontrolled
Stratification	NO
Dynamic allocation	NO
Institution consideration	Institution is not considered as adjustment factor.
Blocking	NO
Concealment	No need to know

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Device,equipment
Interventions/Control_1	From January 2017 to December 2018, admission patients with implantable cardioverter device required the check the unanticipated setting change before and after admission and check the unanticipated setting change using low-output power handy type RFID reader.
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	18 years-old <
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	All patients within the age limit
Key exclusion criteria	Only age
Target sample size	250

Research contact person
Name of lead principal investigator	1st name Middle name Last name Yoshinori Azumi
Organization	Mie university hospital
Division name	Department of Medical Informatics
Zip code
Address	2-174, Edobashi, Tsu, Mie
TEL	059-232-1111
Email	azu1121@clin.medic.mie-u.ac.jp

Public contact
Name of contact person	1st name Middle name Last name Mie university hospital Clinical research ethical review committee
Organization	Mie university hospital
Division name	Clinical research ethical review committee
Zip code
Address	2-174, Edobashi, Tsu, Mie
TEL	059-232-1111
Homepage URL
Email	s-kenkyu@clin.medic.mie-u.ac.jp

Sponsor
Institute	Mia university hospital Department of Medical Informatics
Institute
Department

Funding Source
Organization	None
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

Other related organizations
Co-sponsor	SATO Healthcare co. Astarisk co. Technomedica co. YUYAMA co. S&S Engineering co. Loccioni Group (Italy)
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 10 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	2016 Year 07 Month 07 Day
Date of IRB
Anticipated trial start date	2017 Year 01 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2016 Year 09 Month 09 Day
Last modified on	2017 Year 08 Month 29 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025998

Research Plan
Registered date	File name
2017/08/29	倫理委員会_RFID_20170426.docx

Research case data specifications
Registered date	File name

Research case data
Registered date	File name

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