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Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000023998
Receipt No. R000025998
Official scientific title of the study On-site verification and patient impact investigation of cross check system using ultra high frequency RFID tag and RFID reader
Date of disclosure of the study information 2016/10/01
Last modified on 2016/09/09

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Basic information
Official scientific title of the study On-site verification and patient impact investigation of cross check system using ultra high frequency RFID tag and RFID reader
Title of the study (Brief title) 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

In outcomes field, the entry of just a few words such as "safety" or "efficiency" will not be accepted. Specify the name of outcome measures, including the time when you plan to measure. Usually, only one primary outcome is accepted. Write the other outcomes in "secondary outcomes" field.

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

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

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 Yoshinori Azumi
Organization Mie university hospital
Division name Department of Medical Informatics
Address 2-174, Edobashi, Tsu, Mie
TEL 059-232-1111
Email azu1121@clin.medic.mie-u.ac.jp

Public contact
Name of contact person Mie university hospital Clinical research ethical review committee
Organization Mie university hospital
Division name Clinical research ethical review committee
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

Sponsor means an organization that is responsible for plan, deployment and
report of the research including funding management. It doesn't mean
funding agency". Therefore, all clinical trial should have the one.

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

Other related organizations
Co-sponsor
Name of secondary funder(s)

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

Progress
Recruitment status Preinitiation
Date of protocol fixation
2016 Year 07 Month 07 Day
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

Related information
URL releasing protocol
Publication of results Unpublished
URL releasing results
Results
Other related information

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


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


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