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


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 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


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

Value
https://center6.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