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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000002147
Receipt No. R000002620
Scientific Title Clinical trial of a new assistive device for peripheral vein puncture to take a blood sample and keep an intravenous IV line
Date of disclosure of the study information 2009/07/01
Last modified on 2010/09/24

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Basic information
Public title Clinical trial of a new assistive device for peripheral vein puncture to take a blood sample and keep an intravenous IV line
Acronym A new assistive device for peripheral vein puncture
Scientific Title Clinical trial of a new assistive device for peripheral vein puncture to take a blood sample and keep an intravenous IV line
Scientific Title:Acronym A new assistive device for peripheral vein puncture
Region
Japan

Condition
Condition Puncture of peripheral vein
Classification by specialty
Emergency medicine Intensive care medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Assessment of a new assistive device for peripheral vein puncture to take a blood sample and keep an intravenous IV line
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Phase I,II

Assessment
Primary outcomes Assessment of a new assistive device for safe peripheral vein puncture to take a blood sample and keep an intravenous IV line
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 Treatment
Type of intervention
Device,equipment
Interventions/Control_1 Peripheral vein pucture under assist of test device.
About 5min / 1 procedure
Only 1 procedure / 1 case
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 Persons to be able to undergo peripheral puncture.
Key exclusion criteria Persons to be not able to undergo peripheral puncture.
Target sample size 20

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Toru Yoshida
Organization St. Marianna University School of Medicine
Division name Emergency and Critical Care Medicine
Zip code
Address 2-16-1 Sugao, Miyamae-ku, Kawasaki-City, Kanagawa
TEL 044-977-8111
Email

Public contact
Name of contact person
1st name
Middle name
Last name Toru Yoshida
Organization St. Marianna University School of Medicine
Division name Emergency and Critical Care Medicine
Zip code
Address 2-16-1 Sugao, Miyamae-ku, Kawasaki-City, Kanagawa
TEL 044-977-8111
Homepage URL
Email

Sponsor
Institute St. Marianna University School of Medicine, Emergency and Critical Care Medicine
Institute
Department

Funding Source
Organization Foundation of Ambulance Service Development
Organization
Division
Category of Funding Organization Non profit foundation
Nationality of Funding Organization Japan

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
2009 Year 07 Month 01 Day

Related information
URL releasing protocol
Publication of results Published

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
2009 Year 06 Month 30 Day
Date of IRB
Anticipated trial start date
2009 Year 07 Month 01 Day
Last follow-up date
2010 Year 09 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2009 Year 06 Month 30 Day
Last modified on
2010 Year 09 Month 24 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002620

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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