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UMIN-CTR Clinical Trial |
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Name: | UMIN ID: |
Recruitment status | Enrolling by invitation |
Unique ID issued by UMIN | UMIN000023998 |
Receipt No. | 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 | 2017/08/29 |
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 |
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Condition | ||
Condition | Patient with implantable cardiac device | |
Classification by specialty |
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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 |
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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.
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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 |
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Age-upper limit |
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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 |
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Organization | Mie university hospital | ||||||
Division name | Department of Medical Informatics | ||||||
Zip code | |||||||
Address | 2-174, Edobashi, Tsu, Mie | ||||||
TEL | 059-232-1111 | ||||||
azu1121@clin.medic.mie-u.ac.jp |
Public contact | |||||||
Name of contact person |
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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 | |||||||
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 | |
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 |
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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 |
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Date of IRB | |||||||
Anticipated trial start date |
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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 |
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Last modified on |
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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 |