UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000019311
Receipt number R000022329
Scientific Title The SorbaView SHIELD is a Useful Product for fixation in continuous femoral nerve block
Date of disclosure of the study information 2015/10/11
Last modified on 2015/10/11 11:42:33

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information

Public title

The SorbaView SHIELD is a Useful Product for fixation in continuous femoral nerve block

Acronym

The SorbaView SHIELD is a Useful Product

Scientific Title

The SorbaView SHIELD is a Useful Product for fixation in continuous femoral nerve block

Scientific Title:Acronym

The SorbaView SHIELD is a Useful Product

Region

Japan


Condition

Condition

orthopedics inserted a continuous femoral nerve block

Classification by specialty

Orthopedics Anesthesiology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

safe catheter fixation

Basic objectives2

Safety

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

the degrees of change inserted continuous femoral nerve block

Key secondary outcomes



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

18 years-old <=

Age-upper limit

80 years-old >=

Gender

Male and Female

Key inclusion criteria

the patient inserted a continuous femoral nerve block catheter

Key exclusion criteria

the patient not inserted a continuous femoral nerve block catheter

Target sample size

24


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Hironobu Ueshima

Organization

Showa University Hospital

Division name

Anesthesiology

Zip code


Address

1-5-8, Hatanodai, Shinagawa-ku, Tokyo, Japan

TEL

0337848875

Email

ueshimhi@hirakata.kmu.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Hironobu Ueshima

Organization

Showa University Hospital

Division name

Anesthesiology

Zip code


Address

1-5-8, Hatanodai, Shinagawa-ku, Tokyo, Japan

TEL

0337848875

Homepage URL


Email

ueshimhi@hirakata.kmu.ac.jp


Sponsor or person

Institute

Showa University Hospital

Institute

Department

Personal name



Funding Source

Organization

Showa University Hospital

Organization

Division

Category of Funding Organization

Other

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

大阪府


Other administrative information

Date of disclosure of the study information

2015 Year 10 Month 11 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

Completed

Date of protocol fixation

2015 Year 10 Month 11 Day

Date of IRB


Anticipated trial start date

2015 Year 10 Month 11 Day

Last follow-up date


Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

the degrees of change in an inserted continuous femoral nerve block


Management information

Registered date

2015 Year 10 Month 11 Day

Last modified on

2015 Year 10 Month 11 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022329


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name