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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000005940
Receipt No. R000007020
Scientific Title Comparison of ultrasound visibility of an anesthesia catheter Perifix ONE among 3 ultrasound machines
Date of disclosure of the study information 2011/07/30
Last modified on 2011/07/06

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Basic information
Public title Comparison of ultrasound visibility of an anesthesia catheter Perifix ONE among 3 ultrasound machines
Acronym Ultrasound visibility of anesthesia catheters
Scientific Title Comparison of ultrasound visibility of an anesthesia catheter Perifix ONE among 3 ultrasound machines
Scientific Title:Acronym Ultrasound visibility of anesthesia catheters
Region
Japan

Condition
Condition Chronic upper limb pain
Classification by specialty
Anesthesiology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The aim of this study is to examine the ultrasound visibility and the efficacy of an anesthesia catheter Perifix ONE which is said to have good ultrasound visibility.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Subjective visibility, objective visibility, correlation of the both above, scan time, and success rate.
Key secondary outcomes

Base
Study type Interventional

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

Intervention
No. of arms 4
Purpose of intervention Treatment
Type of intervention
Device,equipment
Interventions/Control_1 Nipro. From October 1 2009.
Interventions/Control_2 Perifix ONE. From October 1 2009.
Interventions/Control_3 Soft Tip. From October 1 2009.
Interventions/Control_4 Unisis. From October 1 2009.
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
80 years-old >
Gender Male and Female
Key inclusion criteria Chronic upper limb pain (Visual Analog Scale > 4) which exist longer than 3 months.
Key exclusion criteria Musculoskeletal disease near brachial plexus.
Target sample size 15

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Junji Takatani
Organization Oita University Hospital
Division name Department of Anesthesiology
Zip code
Address Idaigaoka 1-1, Hasama, Yufu-city, Oita, Japan
TEL
Email

Public contact
Name of contact person
1st name
Middle name
Last name
Organization Oita University Hospital
Division name Department of Anesthesiology
Zip code
Address
TEL
Homepage URL
Email

Sponsor
Institute Oita University Faculty of Medicine
Institute
Department

Funding Source
Organization Self funding
Organization
Division
Category of Funding Organization Self funding
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
2011 Year 07 Month 30 Day

Related information
URL releasing protocol
Publication of results Partially 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 No longer recruiting
Date of protocol fixation
2009 Year 10 Month 01 Day
Date of IRB
Anticipated trial start date
2009 Year 10 Month 01 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
2011 Year 07 Month 06 Day
Last modified on
2011 Year 07 Month 06 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007020

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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