UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000012121 |
|---|---|
| Receipt number | R000014175 |
| Scientific Title | Evaluation of the usability of SMARTVIEW Remote Monitoring system |
| Date of disclosure of the study information | 2013/10/28 |
| Last modified on | 2024/11/18 10:26:20 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Evaluation of the usability of SMARTVIEW Remote Monitoring system
Acronym
SMARTVIEW study
Scientific Title
Evaluation of the usability of SMARTVIEW Remote Monitoring system
Scientific Title:Acronym
SMARTVIEW study
Region
| Japan |
Condition
Condition
Patients with implanted ICD or CRT-D device.
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the usability of Sorin's SMARTVIEW Remote Monitoring system by medical staff and patients.
Basic objectives2
Others
Basic objectives -Others
reliability,satisfaction level
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
To evaluate usability, reliability and satisfaction of Sorin SMARTVIEW Remote Monitoring system by medical staff and patients.
Key secondary outcomes
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1)ICD or CRT-D Patients with Sorin
SMARTVIEW Remote Monitoring system.
2)Patients who use a SMARTVIEW monitor
3)Patients who have a phone line which is accessible to a land line.-except a phone for Internet connection only
4)Patients signed on informed consent
Key exclusion criteria
1)Patients who do not consent
2)Patients have poor health
not suitable for study participation
3)Patients who do not have a phone line which is accessible to a land line
4)Age of less than 20 years
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kenjiro Hara |
Organization
Japan Lifeline Co., Ltd.
Division name
Arrhythmia Business Division
Zip code
Address
6F, Tennoz Central Tower, 2-2-24, Higashishinagawa, Shinagawa-ku, Tokyo 140-0002 Japan
TEL
03-6711-5263
m-nomura@jll.co.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kenjiro Hara |
Organization
Japan Lifeline Co., Ltd.
Division name
Arrhythmia Business Division
Zip code
Address
6F, Tennoz Central Tower, 2-2-24, Higashishinagawa, Shinagawa-ku, Tokyo 140-0002 Japan
TEL
03-6711-5263
Homepage URL
m-nomura@jll.co.jp
Sponsor or person
Institute
Japan Lifeline Co., Ltd.
Institute
Department
Personal name
Funding Source
Organization
Japan Lifeline Co., Ltd.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
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
| 2013 | Year | 10 | Month | 28 | 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
Completed
Date of protocol fixation
| 2013 | Year | 10 | Month | 01 | Day |
Date of IRB
| 2013 | Year | 05 | Month | 01 | Day |
Anticipated trial start date
| 2013 | Year | 11 | Month | 01 | Day |
Last follow-up date
| 2014 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
1)Medical staff are requested to respond to a questionnaire about SMARTVIEW system.
2)Medical staff are requested to hear patients' opinions about SMARTVIEW Monitor.
Management information
Registered date
| 2013 | Year | 10 | Month | 25 | Day |
Last modified on
| 2024 | Year | 11 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014175
