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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000030631
Receipt No. R000034976
Scientific Title Safety study to evaluate the usefulness of optimal needle guide(ONG) under ultrasound-guided CVC
Date of disclosure of the study information 2017/12/29
Last modified on 2017/12/29

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Basic information
Public title Safety study to evaluate the usefulness of optimal needle guide(ONG) under ultrasound-guided CVC
Acronym Usefulness of optimal needle guide(ONG) under ultrasound-guided CVC
Scientific Title Safety study to evaluate the usefulness of optimal needle guide(ONG) under ultrasound-guided CVC
Scientific Title:Acronym Usefulness of optimal needle guide(ONG) under ultrasound-guided CVC
Region
Japan

Condition
Condition candidate for CVC insertion
Classification by specialty
Operative medicine Emergency medicine Intensive care medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To investigate the safely whether the medical doctors who received training program can perform the puncture by ultrasound-guided ONG.
Basic objectives2 Safety
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Phase I

Assessment
Primary outcomes The incidence of multiple puncture
Key secondary outcomes The incidence of complications by the puncture

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Prevention
Type of intervention
Device,equipment
Interventions/Control_1 After the CVC puncture using ultrasound-guided ONG is successful, this intervension will be finished.

The two time of CVC puncture is allowed.
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 1)
more than 20 years old

2)
candidate for CVC insertion
Key exclusion criteria 1)
seriously deteriorated general condition

2)
patients with high fever of moe than 38
degrees

3)
patients with operated scar or infection
in the lesion of puncture

4)
not appropriate for the registration of
this study according to physician's
judgement
Target sample size 16

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Kyoichi Kaira
Organization Gunma University Hospital
Division name Innovative medical Research Center
Zip code
Address 3-39-15, showa-machi, maebashi, Gunma, Japan
TEL 027-220-8347
Email kkaira1970@yahoo.co.jp

Public contact
Name of contact person
1st name
Middle name
Last name Kyoichi Kaira
Organization Gunma University Hospital
Division name Innovative medical Research Center
Zip code
Address 3-39-15, showa-machi, maebashi, Gunma, Japan
TEL 027-220-8347
Homepage URL http://imrc.med.gunma-u.ac.jp/
Email kkaira1970@yahoo.co.jp

Sponsor
Institute AMED
Institute
Department

Funding Source
Organization AMED
Organization
Division
Category of Funding Organization Japanese Governmental office
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
2017 Year 12 Month 29 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 Enrolling by invitation
Date of protocol fixation
2017 Year 10 Month 01 Day
Date of IRB
Anticipated trial start date
2017 Year 11 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
2017 Year 12 Month 29 Day
Last modified on
2017 Year 12 Month 29 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034976

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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