UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000058328
Receipt number R000065784
Scientific Title Echo-guided Puncture: Development of a Simple Guide for Easy Needle Visualization
Date of disclosure of the study information 2025/07/01
Last modified on 2025/07/01 07:39:56

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Basic information

Public title

How can the needle be easily visualized during echo-guided puncture? Development of a simple guide.

Acronym

Echo-Puncture Guide

Scientific Title

Echo-guided Puncture: Development of a Simple Guide for Easy Needle Visualization

Scientific Title:Acronym

EG-Guide

Region

Japan


Condition

Condition

Simulated Conditions Requiring Puncture

Classification by specialty

Not applicable

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

The aim of this study is to explore methods that support skill development and enable even beginners to easily visualize the needle in freehand procedures.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

The primary endpoint will be evaluated using the in-plane technique.

Key secondary outcomes



Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Cluster

Blinding

Double blind -all involved 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

Maneuver

Interventions/Control_1

A guide for advancing the puncture needle parallel using the plane of an attached plate.

Interventions/Control_2

Control

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

65 years-old >

Gender

Male and Female

Key inclusion criteria

Nurses and students with no experience in echo-guided puncture.

Key exclusion criteria

Individuals with upper limb disabilities, visual impairments, and those refusing participation.

Target sample size

32


Research contact person

Name of lead principal investigator

1st name Satoki
Middle name
Last name Inoue

Organization

Fukushima Medical University

Division name

Anesthesiology

Zip code

960-1295

Address

1 Hikarigaoka Fukushima City Fukushima

TEL

024-567-1342

Email

seninoue@fmu.ac.jp


Public contact

Name of contact person

1st name Satoki
Middle name
Last name Inoue

Organization

Fukushima Medical University

Division name

Aaesthesiology

Zip code

960-1295

Address

1 Hikarigaoka Fukushima City Fukushima

TEL

024-567-1342

Homepage URL


Email

seninoue@fmu.ac.jp


Sponsor or person

Institute

Fukushima Medical University

Institute

Department

Personal name



Funding Source

Organization

Fukushima Medical University

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

Fukushima Medical University

Address

1 Hikarigaoka Fukushima City Fukushima

Tel

0245471342

Email

seninoue@fmu.ac.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

2025 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


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

2025 Year 04 Month 08 Day

Date of IRB

2025 Year 04 Month 09 Day

Anticipated trial start date

2025 Year 04 Month 11 Day

Last follow-up date

2025 Year 05 Month 15 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

Ethical committee approval is not required. The approval date has been included for convenience, as it is required for registration.









Management information

Registered date

2025 Year 07 Month 01 Day

Last modified on

2025 Year 07 Month 01 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000065784