UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000041130
Receipt number R000046967
Scientific Title Flow characteristics of three non-Luer spinal needle types
Date of disclosure of the study information 2020/07/16
Last modified on 2020/07/16 21:29:52

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Basic information

Public title

Flow characteristics of non-Luer spinal needles

Acronym

Flow characteristics of non-Luer spinal needles

Scientific Title

Flow characteristics of three non-Luer spinal needle types

Scientific Title:Acronym

Flow characteristics of three non-Luer spinal needle types

Region

Japan


Condition

Condition

spinal anesthesia

Classification by specialty

Anesthesiology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

The primary objective of this study is to compare the non-Luer needles from three companies and to reveal the fastest outflow needles

Basic objectives2

Others

Basic objectives -Others

Features of medical devices

Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

The outflow flom spinal needles

Key secondary outcomes



Base

Study type

Others,meta-analysis etc


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


Not applicable

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

non

Key exclusion criteria

non

Target sample size



Research contact person

Name of lead principal investigator

1st name Kyuma
Middle name
Last name Omi

Organization

Hitachi General Hospital

Division name

anesthesia department

Zip code

317-0077

Address

Jonan 2-1-1, Hitachi, Ibaraki, japan

TEL

0294-23-1111

Email

kyuma.omi.ec@hitachi.com


Public contact

Name of contact person

1st name Kyuma
Middle name
Last name Omi

Organization

Hitachi General Hospital

Division name

anesthesia department

Zip code

317-0077

Address

Jonan 2-1-1, Hitachi, Ibaraki, japan

TEL

0294-23-1111

Homepage URL


Email

kyuma.omi.ec@hitachi.com


Sponsor or person

Institute

Hitachi General Hospital

Institute

Department

Personal name



Funding Source

Organization

Hitachi General Hospital

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

Hitachi General Hospital

Address

Jonan 2-1-1, Hitachi, Ibaraki, japan

Tel

0294-23-1111

Email

kyuma.omi.ec@hitachi.com


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

2020 Year 07 Month 16 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

Preinitiation

Date of protocol fixation

2020 Year 07 Month 15 Day

Date of IRB


Anticipated trial start date

2020 Year 07 Month 17 Day

Last follow-up date

2021 Year 10 Month 01 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

using model


Management information

Registered date

2020 Year 07 Month 16 Day

Last modified on

2020 Year 07 Month 16 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046967


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name