UMIN-CTR Clinical Trial

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
Email	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
Email	kmkodaka@cb3.so-net.ne.jp

Sponsor
Institute	TOKYO WOMEN'S MEDICAL CENTER EAST
Institute
Department

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
Email	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045033