UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000041569 |
|---|---|
| Receipt number | R000045033 |
| Scientific Title | Variation in the axillary brachial plexus detected via ultrasonography and nerve stimulation |
| Date of disclosure of the study information | 2020/08/27 |
| Last modified on | 2020/08/27 05:50:11 |
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Basic information
Public title
Variation in the axillary brachial plexus detected via ultrasonography and nerve stimulation
Acronym
Variation in the axillary brachial plexus detected via ultrasonography and nerve stimulation
Scientific Title
Variation in the axillary brachial plexus detected via ultrasonography and nerve stimulation
Scientific Title:Acronym
Variation in the axillary brachial plexus detected via ultrasonography and nerve stimulation
Region
| Japan |
Condition
Condition
volunteer
Classification by specialty
| Anesthesiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
There are few reports that researched anatomical variation of brachial plexus using both ultrasonography and a pen-type nerve stimulator via skin. On the other hand, most of previous references reported either left or right side of brachial plexus anatomically due to orthopedic operations. Therefore, we originally compared the difference between both sides of nerve positions for each case.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The mean and standard deviation value of each nerve angle (left and right) was evaluated and the difference between left and right would be shown in Figure .
Key secondary outcomes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| 65 | years-old | > |
Gender
Male and Female
Key inclusion criteria
HEALTY ADULTS VOLUNTEERS
Key exclusion criteria
DIFFICULT TO UNDERSTAND JAPANESE
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Mitsuharu |
| Middle name | |
| Last name | Kodaka |
Organization
Tokyo Women's Medical University, Medical Center East
Division name
ANESTHESIOLOGY
Zip code
116-8567
Address
2-1-10 Nishi-ogu ARAKAWAKU TOKYO
TEL
+81338101111
kmkodaka@cb3.so-net.ne.jp
Public contact
Name of contact person
| 1st name | Mitsuharu |
| Middle name | |
| Last name | Kodaka |
Organization
Tokyo Women's Medical University, Medical Center East
Division name
ANESTHESIOLOGY
Zip code
116-8567
Address
2-1-10 Nishi-ogu ARAKAWAKU TOKYO
TEL
+81338101111
Homepage URL
kmkodaka@cb3.so-net.ne.jp
Sponsor or person
Institute
TOKYO WOMEN'S MEDICAL CENTER EAST
Institute
Department
Personal name
Funding Source
Organization
TOKYO WOMEN'S MEDICAL CENTER EAST
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Tokyo Women's Medical University, Medical Center East
Address
2-1-10 Nishi-ogu AKAKAWAKU TOKYO
Tel
+81338101111
kmkodaka@cb3.so-net.ne.jp
Secondary IDs
Secondary IDs
YES
Study ID_1
4679
Org. issuing International ID_1
TOKYO WOMEN'S MEDICAL UNIVERSITY
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2020 | Year | 08 | Month | 27 | 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
36
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
| 2017 | Year | 03 | Month | 01 | Day |
Date of IRB
| 2017 | Year | 03 | Month | 01 | Day |
Anticipated trial start date
| 2017 | Year | 03 | Month | 01 | Day |
Last follow-up date
| 2020 | Year | 03 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Observatory trial
Management information
Registered date
| 2020 | Year | 08 | Month | 27 | Day |
Last modified on
| 2020 | Year | 08 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045033
