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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000034828
Receipt No. R000039075
Official scientific title of the study Cutaneous blood flow assessment with a wireless device.
Date of disclosure of the study information 2018/11/09
Last modified on 2018/11/09

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Basic information
Official scientific title of the study Cutaneous blood flow assessment with a wireless device.
Title of the study (Brief title) blood flow assessment
Region
Japan

Condition
Condition blood flow
Classification by specialty
Not applicable
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To evaluate oxyhemoglobin and deoxyhemoglobin with an wireless device. Changes after arterior or venous clamping will be evaluated.
Basic objectives2 Others
Basic objectives -Others Oxyhemoglobin and deoxyhemoglobin changes after arterior or venous clamping will be evaluated by voltage changes transmitted by an wireless device.
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Oxyhemoglobin and deoxyhemoglobin changes after arterior or venous clamping will be evaluated.
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 Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Prevention
Type of intervention
Maneuver
Interventions/Control_1 pressurize with a cuff
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
100 years-old >=
Gender Male
Key inclusion criteria healthy
Key exclusion criteria with any illness
Target sample size 5

Research contact person
Name of lead principal investigator Soh Nishimoto
Organization Hyogo College of Medicine
Division name Plastic Surgery
Address 1-1Mukogawacho Nishinomiya
TEL 0798456753
Email nishimot@hyo-med.ac.jp

Public contact
Name of contact person Soh Nishimoto
Organization Hyogo College of Medicine
Division name Plastic Surgery
Address 1-1Mukogawacho Nishinomiya
TEL 0798456753
Homepage URL
Email nishimot@hyo-med.ac.jp

Sponsor
Institute Hyogo College of Medicine
Institute
Department

Funding Source
Organization Genial Light Co.ltd
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

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
2018 Year 11 Month 09 Day

Progress
Recruitment status Enrolling by invitation
Date of protocol fixation
2018 Year 04 Month 01 Day
Anticipated trial start date
2018 Year 11 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results Unpublished
URL releasing results
Results
Other related information

Management information
Registered date
2018 Year 11 Month 09 Day
Last modified on
2018 Year 11 Month 09 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039075

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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