UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000002147 |
|---|---|
| Receipt number | 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 08:26:12 |
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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
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
Sponsor or person
Institute
St. Marianna University School of Medicine, Emergency and Critical Care Medicine
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002620
