UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000024247
Receipt No. R000027918
Scientific Title assessment of the efficacy of needle guide kit for in-plane approach of needle insertion under ultrasound guidance
Date of disclosure of the study information 2016/09/30
Last modified on 2018/01/13

* 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 assessment of the efficacy of needle guide kit for in-plane approach of needle insertion under ultrasound guidance
Acronym assessment of the efficacy of needle guide kit
Scientific Title assessment of the efficacy of needle guide kit for in-plane approach of needle insertion under ultrasound guidance
Scientific Title:Acronym assessment of the efficacy of needle guide kit
Region
Japan

Condition
Condition medical students
Classification by specialty
Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The aim of this study is to assess any potential advantage (speed and quality) in use of needle guide kit for in-plane approach of needle insertion under ultrasound guidance.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes The time from needle entry into phantom until the target is contacted
The assessment of quality of needle imaging by the observer
The number of times requested to modify by the observer
Key secondary outcomes The assessment of difficulty of needle insertion by the participants

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Educational,Counseling,Training
Type of intervention
Maneuver
Interventions/Control_1 Use of needle guide kit/No use of needle guide kit
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 Medical students in the Hamamatsu University School of Medicine
Key exclusion criteria Students who do not agree to participate in this study
Target sample size 20

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Tetsuro Kimura
Organization Hamamatsu University School of Medicine
Division name Department of Anesthesiology and Intensive Care
Zip code
Address 1-20-1 Handayama, Higashi-ku, Hamamatsu, Shizuoka, 431-3192, Japan
TEL +81-53-435-2286
Email t-kimura@hama-med.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Tetsuro Kimura
Organization Hamamatsu University School of Medicine
Division name Department of Anesthesiology and Intensive Care
Zip code
Address 1-20-1 Handayama, Higashi-ku, Hamamatsu, Shizuoka, 431-3192, Japan
TEL +81-53-435-2286
Homepage URL
Email t-kimura@hama-med.ac.jp

Sponsor
Institute Department of Anesthesiology and Intensive Care, Hamamatsu University School of Medicine
Institute
Department

Funding Source
Organization None
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
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 浜松医科大学附属病院(静岡県)

Other administrative information
Date of disclosure of the study information
2016 Year 09 Month 30 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
Time to reach target was shorter in each needle guide groups than Free-hand group.
The quality of needle visibility and the difficulty of needle insertion were better in in the needle guide group than Free-hand group in all settings.
There was no significant difference between the two needle guide groups. 
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
2016 Year 09 Month 30 Day
Date of IRB
Anticipated trial start date
2016 Year 10 Month 01 Day
Last follow-up date
2016 Year 12 Month 31 Day
Date of closure to data entry
2017 Year 03 Month 31 Day
Date trial data considered complete
2017 Year 03 Month 31 Day
Date analysis concluded
2017 Year 03 Month 31 Day

Other
Other related information

Management information
Registered date
2016 Year 09 Month 30 Day
Last modified on
2018 Year 01 Month 13 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027918

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.