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

Email

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


Email

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


Email



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


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name