UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000020226 |
|---|---|
| Receipt number | R000023355 |
| Scientific Title | Fundamental Study on peripheral circulation evaluation using mobile laser blood flow meter |
| Date of disclosure of the study information | 2015/12/21 |
| Last modified on | 2017/06/19 17:42:25 |
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Basic information
Public title
Fundamental Study on peripheral circulation evaluation using mobile laser blood flow meter
Acronym
Fundamental Study on peripheral circulation evaluation using mobile laser blood flow meter
Scientific Title
Fundamental Study on peripheral circulation evaluation using mobile laser blood flow meter
Scientific Title:Acronym
Fundamental Study on peripheral circulation evaluation using mobile laser blood flow meter
Region
| Japan |
Condition
Condition
healthy subject
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To develop a method for peripheral circulation evaluation by blood flow meter.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Changes in peripheral circulation, blood pressure, body temperature which caused by positions conversion, pressure, warming.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Device,equipment | Behavior,custom |
Interventions/Control_1
Change in body position, application of pressure, warming.
The duration of the test is about 2 hours, held for a different group of participants.
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
Healthy subjects over 20 years of age
Key exclusion criteria
Healthy person who did not agree to be included in the study.
Subjects who are unsuitable for the entry judged by a doctor.
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Michio Mineshima |
Organization
Tokyo Women's Medical University
Division name
Department of Clinical Engineering
Zip code
Address
8-1 Kawada-cho, Shinjuku-ku, Tokyo, 162-8666,Japan.
TEL
03-3353-8111
mmine@twmu.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kei Eguchi |
Organization
Tokyo Women's Medical University
Division name
Department of Clinical Engineering
Zip code
Address
8-1 Kawada-cho, Shinjuku-ku, Tokyo, 162-8666,Japan.
TEL
03-3353-8111
Homepage URL
eguchi.kei@twmu.ac.jp
Sponsor or person
Institute
Tokyo Women's Medical University
Institute
Department
Personal name
Funding Source
Organization
Grant-in-Aid for Scientific Research
Organization
Division
Category of Funding Organization
Japanese Governmental office
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
| 2015 | Year | 12 | Month | 21 | 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
| 2015 | Year | 10 | Month | 23 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 12 | Month | 21 | 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
| 2015 | Year | 12 | Month | 16 | Day |
Last modified on
| 2017 | Year | 06 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023355
