UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000048777 |
|---|---|
| Receipt number | R000055571 |
| Scientific Title | Risk analysis in intramuscular vaccine injection |
| Date of disclosure of the study information | 2022/08/27 |
| Last modified on | 2022/08/27 20:34:48 |
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Basic information
Public title
Risk analysis in intramuscular vaccine injection
Acronym
Risk analysis in intramuscular vaccine injection
Scientific Title
Risk analysis in intramuscular vaccine injection
Scientific Title:Acronym
Risk analysis in intramuscular vaccine injection
Region
| Japan |
Condition
Condition
healthy volunteer
Classification by specialty
| Anesthesiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This is the first time in human history that such so many intramuscular injections of vaccines by COVID 19 has been carried out worldwide. In proportion of the total number of vaccine receivers, there has been increased reports of complications, such as damage to the axillary nerve, posterior brachial circumflex artery, by triangular intramuscular injections.
These complications are generally called as shoulder injury related to vaccine administration (SIRVA), that have developed into medical lawsuits.
The purpose was to research volunteers placing an echo probe around the deltoid muscle, and we measure the distance from nerves, arteries, joint capsules, etc., and create a new muscle injection point with less complications using echo image.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
In volunteers, echo is applied to the deltoid muscle and the running of the axillary and radial nerves is visualized as a continuous line.
Indicate the injection point of the vaccine and save it as a image for analysis. Then arm position(internal rotation/external rotation) is kept constant. When using a neurostimulator to ensure each nerve identification
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
nothing
Key exclusion criteria
nothing
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 SCHOOL ADACHI MEDICAL CENTER
Division name
ICU
Zip code
123-8558
Address
4-33-1 KOHOKU ADACHI-KU TOKYO
TEL
03-3857-0111
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 SCHOOL ADACHI MEDICAL CENTER
Division name
ICU
Zip code
123-8558
Address
4-33-1 KOHOKU ADACHI-KU TOKYO
TEL
03-3857-0111
Homepage URL
kmkodaka@cb3.so-net.ne.jp
Sponsor or person
Institute
TOKYO WOMEN'S MEDICAL SCHOOL ADACHI MEDICAL CENTER
Institute
Department
Personal name
Funding Source
Organization
TOKYO WOMEN'S MEDICAL SCHOOL ADACHI MEDICAL CENTER
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 SCHOOL ADACHI MEDICAL CENTER
Address
4-33-1 KOHOKU ADACHI-KU TOKYO
Tel
0338570111
kmkodaka@cb3.so-net.ne.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
| 2022 | 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
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
| 2022 | Year | 08 | Month | 27 | Day |
Date of IRB
Anticipated trial start date
| 2022 | Year | 10 | Month | 12 | Day |
Last follow-up date
| 2023 | Year | 01 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
NOTHING
Management information
Registered date
| 2022 | Year | 08 | Month | 27 | Day |
Last modified on
| 2022 | 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=R000055571
