UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000023998
Receipt number R000025998
Scientific Title 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 2021/09/13 18:26:38

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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 Yoshinori
Middle name
Last name Azumi

Organization

Mie university hospital

Division name

Department of Medical Informatics

Zip code

5148507

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 Clinical research ethical review committee
Middle name
Last name Mie university hospital

Organization

Mie university hospital

Division name

Clinical research ethical review committee

Zip code

5148507

Address

2-174, Edobashi, Tsu, Mie

TEL

059-232-1111

Homepage URL


Email

s-kenkyu@clin.medic.mie-u.ac.jp


Sponsor or person

Institute

Mia university hospital Department of Medical Informatics

Institute

Department

Personal name



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

Mie University Hospital

Address

2-174 Edobashi, Tsu, Mie, Japan

Tel

059-232-1111

Email

s-kenkyu@clin.medic.mie-u.ac.jp


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

三重大学医学部附属病院


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

2016 Year 09 Month 21 Day

Anticipated trial start date

2017 Year 01 Month 01 Day

Last follow-up date

2020 Year 12 Month 31 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded

2021 Year 03 Month 31 Day


Other

Other related information



Management information

Registered date

2016 Year 09 Month 09 Day

Last modified on

2021 Year 09 Month 13 Day



Link to view the page

Value
https://center6.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