UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000004638
Receipt No. 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

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


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
Email

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
Email

Sponsor
Institute Nippon Becton Dickinson Company, Ltd.
Institute
Department

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
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
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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005533

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.