UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000055234 |
|---|---|
| Receipt number | R000063104 |
| Scientific Title | Exploring the Utility of a Novel Needle Guide in Ultrasound-Guided Puncture |
| Date of disclosure of the study information | 2024/09/01 |
| Last modified on | 2024/10/08 12:50:52 |
* 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
Exploring the Utility of a Novel Needle Guide in Ultrasound-Guided Puncture
Acronym
Exploring the Utility of a Novel Needle Guide in Ultrasound-Guided Puncture
Scientific Title
Exploring the Utility of a Novel Needle Guide in Ultrasound-Guided Puncture
Scientific Title:Acronym
Exploring the Utility of a Novel Needle Guide in Ultrasound-Guided Puncture
Region
| Japan |
Condition
Condition
Echo-Guided Puncture Techniques Using an Echo Phantom
Classification by specialty
| Not applicable |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
In medical procedures such as arterial puncture, central venous catheterization, and peripheral nerve blocks, it is beneficial to use ultrasound devices to visualize the target while guiding the puncture needle to the desired location on the echo screen, enhancing both safety and accuracy. However, even for experienced practitioners, accurately depicting the needle on the ultrasound screen can be challenging. This study will investigate the utility of a novel needle guide in ultrasound-guided puncture using an echo phantom.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Distance between the target and the needle
Time taken to puncture the target
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
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
Ultrasound-Guided Puncture Using a Novel Needle Guide
Interventions/Control_2
Ultrasound-Guided Puncture Without a Needle Guide
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Medical doctor
Key exclusion criteria
If consent is not obtained
Target sample size
15
Research contact person
Name of lead principal investigator
| 1st name | Michiko |
| Middle name | |
| Last name | Kinoshita |
Organization
Tokushima University Hospital
Division name
Department of Anesthesiology
Zip code
770-8503
Address
2-50-1 Kuramoto-cho, Tokushima-shi, Tokushima
TEL
088-633-7181
michiko-kinoshita@tokushima-u.ac.jp
Public contact
Name of contact person
| 1st name | Michiko |
| Middle name | |
| Last name | Kinoshita |
Organization
Tokushima University Hospital
Division name
Department of Anesthesiology
Zip code
770-8503
Address
2-50-1 Kuramoto-cho, Tokushima-shi, Tokushima
TEL
088-633-7181
Homepage URL
michiko-kinoshita@tokushima-u.ac.jp
Sponsor or person
Institute
Tokushima University
Institute
Department
Personal name
Funding Source
Organization
Self funding
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
Tokushima University Hospital
Address
2-50-1, Kuramoto-cho, Tokushima-shi, Tokushima
Tel
088-633-7181
michiko-kinoshita@tokushima-u.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
| 2024 | Year | 09 | 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
Enrolling by invitation
Date of protocol fixation
| 2024 | Year | 09 | Month | 01 | Day |
Date of IRB
| 2024 | Year | 09 | Month | 30 | Day |
Anticipated trial start date
| 2024 | Year | 10 | Month | 10 | Day |
Last follow-up date
| 2026 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2024 | Year | 08 | Month | 13 | Day |
Last modified on
| 2024 | Year | 10 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000063104
