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UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000013420
Receipt No. R000015403
Scientific Title Examination about BD NexivaTM closed IV Catheter System of use in peripheral intravenous or intra-arterial cannulation.
Date of disclosure of the study information 2014/03/15
Last modified on 2017/01/24

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Basic information
Public title Examination about BD NexivaTM closed IV Catheter System of use in peripheral intravenous or intra-arterial cannulation.
Acronym Examination about BD NexivaTM closed IV Catheter System of use in peripheral intravenous or intra-arterial cannulation.
Scientific Title Examination about BD NexivaTM closed IV Catheter System of use in peripheral intravenous or intra-arterial cannulation.
Scientific Title:Acronym Examination about BD NexivaTM closed IV Catheter System of use in peripheral intravenous or intra-arterial cannulation.
Region
Japan

Condition
Condition The patients aged 20-85 years old, who were ASA-PS 1-3.
Classification by specialty
Anesthesiology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 We studied the efficacy and safety of BD Nexiva TM for intravenous and intra-arterial cannulation, by comparing clinically BD Nexiva TM and a conventional catheter needle( Surshield Surflo II).
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Primary outcomes were the number of blood exposures for cannulation, and the number of attempts at insertion of the cannula.
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit
Blinding Single blind -participants are blinded
Control Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Device,equipment
Interventions/Control_1 BD Nexiva TM .
Interventions/Control_2 Surshield Surflo II.
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
85 years-old >=
Gender Male and Female
Key inclusion criteria Patients who were scheduled for elective surgery ,and who were ASA-PS 1-3.
Key exclusion criteria Patients who were diagnosed arteriosclerotic disease ( coronary artery disease, cerebrovascular disease, arteriosclerosis obliterans, etc.).
Target sample size 40

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yuki Maruyama
Organization Shinshu University School of Medicine
Division name Department of Anesthesiology and Resuscitology
Zip code
Address 3-1-1 Asahi, Matsumoto, Nagano
TEL 0263-37-2670
Email y5maruyama@shinshu-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Satoshi Tanaka
Organization Shinshu University School of Medicine
Division name Department of Anesthesiology and Resuscitology
Zip code
Address 3-1-1 Asahi, Matsumoto, Nagano
TEL 0263-37-2670
Homepage URL
Email s_tanaka@shinshu-u.ac.jp

Sponsor
Institute Department of Anesthesiology and Resuscitology, University School of Medicine
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
2014 Year 03 Month 15 Day

Related information
URL releasing protocol
Publication of results Unpublished

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 Terminated
Date of protocol fixation
2014 Year 02 Month 08 Day
Date of IRB
Anticipated trial start date
2014 Year 03 Month 15 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2014 Year 03 Month 14 Day
Last modified on
2017 Year 01 Month 24 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015403

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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