UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000036974
Receipt number R000042120
Scientific Title Utility of needle tip enhancement function in ultrasound guided nerve block for deep nerve block
Date of disclosure of the study information 2019/07/01
Last modified on 2021/06/08 16:17:02

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Basic information

Public title

Utility of needle tip enhancement function in ultrasound guided nerve block for deep nerve block

Acronym

Utility of needle tip enhancement function in ultrasound guided nerve block

Scientific Title

Utility of needle tip enhancement function in ultrasound guided nerve block for deep nerve block

Scientific Title:Acronym

Utility of needle tip enhancement function in ultrasound guided nerve block

Region

Japan


Condition

Condition

Cadaver

Classification by specialty

Anesthesiology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

Compare ultrasound images of deep blocks with and without needle tip enhancement function.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Visibility of needle tip

Key secondary outcomes



Base

Study type

Interventional


Study design

Basic design

Factorial

Randomization

Non-randomized

Randomization unit


Blinding

Single blind -participants are blinded

Control

No treatment

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

2

Purpose of intervention

Educational,Counseling,Training

Type of intervention

Device,equipment

Interventions/Control_1

With needle tip enhancement function

Interventions/Control_2

Without needle tip enhancement function

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

24 years-old <=

Age-upper limit

60 years-old >=

Gender

Male and Female

Key inclusion criteria

Anesthesiologist with ultrasound-guided nerve blocks experience

Key exclusion criteria

Other than those above

Target sample size

20


Research contact person

Name of lead principal investigator

1st name Joho
Middle name
Last name Tokumine

Organization

Kyorin University School of Medicine

Division name

Department of Anesthesiology

Zip code

181-8611

Address

Shinawa 6-20-2 Mitaka city Tokyo Japan

TEL

0422475511

Email

kunitarowatanabe@yahoo.co.jp


Public contact

Name of contact person

1st name Kunitaro
Middle name
Last name Watanabe

Organization

Kyorin University School of Medicine

Division name

Department of Anesthesiology

Zip code

181-8611

Address

Shinawa 6-20-2 Mitaka city Tokyo Japan

TEL

0422475511

Homepage URL


Email

kunitarowatanabe@yahoo.co.jp


Sponsor or person

Institute

Kyorin University School of Medicine
Department of Anesthesiology

Institute

Department

Personal name



Funding Source

Organization

FUJIFILM Medical Corporation

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

Kyorin University School of Medicine

Address

Mitaka city Shinkawa 6-20-2, Tokyo, Japan

Tel

0422475511

Email

kunitarowatanabe@yahoo.co.jp


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

2019 Year 07 Month 01 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

30

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

Main results already published

Date of protocol fixation

2019 Year 06 Month 04 Day

Date of IRB

2019 Year 11 Month 30 Day

Anticipated trial start date

2020 Year 02 Month 01 Day

Last follow-up date

2020 Year 07 Month 31 Day

Date of closure to data entry

2020 Year 08 Month 01 Day

Date trial data considered complete

2020 Year 08 Month 01 Day

Date analysis concluded

2020 Year 09 Month 20 Day


Other

Other related information



Management information

Registered date

2019 Year 06 Month 05 Day

Last modified on

2021 Year 06 Month 08 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042120


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name