UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000004638 |
|---|---|
| Receipt number | R000005533 |
| Scientific Title | Investigation of Clinical Usefulness of All-in-One Peripheral Intravenous Catheter System |
| Date of disclosure of the study information | 2010/12/01 |
| Last modified on | 2013/02/26 10:37:33 |
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Basic information
Public title
Investigation of Clinical Usefulness of All-in-One Peripheral Intravenous Catheter System
Acronym
Clinical evaluation of all-in-one peripheral intravenous catheter system
Scientific Title
Investigation of Clinical Usefulness of All-in-One Peripheral Intravenous Catheter System
Scientific Title:Acronym
Clinical evaluation of all-in-one peripheral intravenous catheter system
Region
| Japan |
Condition
Condition
not Specified
Classification by specialty
| Not applicable |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Closed catheter system, in which an extension tube and catheter are in one system, has been developed based on a new concept, and is investigated its clinical usefulness by comparing with existing catheter.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
A re-start rate of new catheter and existing one.
The re-start rate is defined that a catheter has to be removed due to any reasons including blockage of the catheter, complication such as phlebitis and the like and is replaced with a new catheter.
Key secondary outcomes
Events including loosening or displacement of securing site or bending or kink of the catheter or phlebitis or infiltration.
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
Patients who are expected to catheter insertion more than 72 hours
Catheter insertion can be done at the back of the hand, forearm, upper arm or leg
Key exclusion criteria
Patients who have once enrolled in the Investigation. However, patients who are discharged from the study site during the study period and are again admitted are NOT excluded.
Pregnant women
Patients who have any one of skin inflammations, burns, other skin lesions and tattoos, etc is at or near a catheter insertion site
Patients who have limited insertion sites such as the bending areas of the upper and lower extremities
Patients who are in anti-cancer drug therapy
Patients who are known their sensitivity to medical adhesive materials like dressing materials
Patients who need antibiotics or ointment locally under the dressing material
Patients who are perspirating when inserting a catheter
Patients who are judged inappropriate to enroll in the Investigation by a physician or a nurse
Target sample size
400
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Naoaki Tamura |
Organization
Koto Hospital
Division name
Deputy Director, Internal Medicine
Zip code
Address
6-8-5 Ohshima, Koto-ku, Tokyo
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Takeshi Tomaru |
Organization
Nippon Becton Dickinson Company, Ltd.
Division name
Clinical Development, Medical Affairs
Zip code
Address
Akasaka Garden City 4-1-15, Akasaka, Minato-ku, Tokyo
TEL
03-6234-5490
Homepage URL
Sponsor or person
Institute
Nippon Becton Dickinson Company, Ltd.
Institute
Department
Personal name
Funding Source
Organization
Nippon Becton Dickinson Company, Ltd.
Organization
Division
Category of Funding Organization
Profit organization
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
| 2010 | Year | 12 | 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
| 2010 | Year | 09 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2010 | Year | 12 | Month | 01 | Day |
Last follow-up date
| 2011 | Year | 09 | Month | 30 | Day |
Date of closure to data entry
| 2012 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2012 | Year | 05 | Month | 31 | Day |
Date analysis concluded
| 2012 | Year | 07 | Month | 31 | Day |
Other
Other related information
Prospective, Opnen, Non-randomization
Management information
Registered date
| 2010 | Year | 11 | Month | 30 | Day |
Last modified on
| 2013 | Year | 02 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005533
