UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000059592 |
|---|---|
| Receipt number | R000068167 |
| Scientific Title | Accuracy of Color Overlay Assisted Ultrasound Imaging for Brachial Plexus Identification A Prospective Validation Study |
| Date of disclosure of the study information | 2025/11/20 |
| Last modified on | 2025/10/30 16:38:26 |
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Basic information
Public title
Evaluating a New Color Overlay Ultrasound Function for Identifying Nerves
Acronym
Evaluating a New Color Overlay Ultrasound Function for Identifying Nerves
Scientific Title
Accuracy of Color Overlay Assisted Ultrasound Imaging for Brachial Plexus Identification A Prospective Validation Study
Scientific Title:Acronym
Accuracy of Color Overlay Assisted Ultrasound Validation Study
Region
| Japan |
Condition
Condition
Adult
Classification by specialty
| Anesthesiology | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study aims to objectively evaluate how accurately the C5 and C6 nerve roots can be identified during interscalene brachial plexus block using the color overlay functions (cNerve on GE Venue Go and VisNerve on Konica Minolta SONIMAGE), quantified by a confusion matrix (TP, FP, TN, FN).
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Sensitivity, specificity, and accuracy = (TP + TN) / total number of structures (= TPr + TNr)
Key secondary outcomes
TP (True Positive)
TN (True Negative)
FP (False Positive)
FN (False Negative)
PPV (Positive Predictive Value)
NPV (Negative Predictive Value)
Time to image acquisition
Optimal image acquisition rate
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Diagnosis
Type of intervention
| Device,equipment |
Interventions/Control_1
Ultrasound images of the neck were obtained for identification of the brachial plexus.
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Inclusion Criteria
Individuals aged 20 years or older at the time of consent.
Individuals without any cervical (neck) disease or trauma.
Individuals who have provided written informed consent to participate in the study.
Key exclusion criteria
Exclusion Criteria
Individuals whose ability to provide informed consent cannot be confirmed.
Individuals judged by the investigators to be otherwise unsuitable for participation in this study.
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Yuji |
| Middle name | |
| Last name | Kamimura |
Organization
Nagoya City University Graduate School of Medical Sciences
Division name
Department of Anesthesiology and Intensive Care Medicine
Zip code
467-8601
Address
1 Kawasumi, Mizuho-cho, Mizuho-ku, Nagoya, Aichi, Japan
TEL
0528515511
ez4pixy1118@gmail.com
Public contact
Name of contact person
| 1st name | Yuji |
| Middle name | |
| Last name | Kamimura |
Organization
Nagoya City University Graduate School of Medical Sciences
Division name
Department of Anesthesiology and Intensive Care Medicine
Zip code
467-8601
Address
1 Kawasumi, Mizuho-cho, Mizuho-ku, Nagoya, Aichi, Japan
TEL
0528518281
Homepage URL
ez4pixy1118@gmail.com
Sponsor or person
Institute
Nagoya city university
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
Nagoya City University Institutional Review Board
Address
1 Kawasumi, Mizuho-cho, Mizuho-ku, Nagoya, Aichi, Japan
Tel
0528538582
irb_jimu@med.nagoya-cu.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 | 11 | Month | 20 | 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
Preinitiation
Date of protocol fixation
| 2025 | Year | 11 | Month | 15 | Day |
Date of IRB
Anticipated trial start date
| 2025 | Year | 11 | Month | 20 | 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
| 2025 | Year | 10 | Month | 30 | Day |
Last modified on
| 2025 | Year | 10 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000068167
