UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000030631
Receipt number 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 01:11:06

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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 or person

Institute

AMED

Institute

Department

Personal name



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

Value
https://center6.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