UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000024247 |
|---|---|
| Receipt number | 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 08:42:23 |
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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
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
t-kimura@hama-med.ac.jp
Sponsor or person
Institute
Department of Anesthesiology and Intensive Care, Hamamatsu University School of Medicine
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027918
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
