UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000040320 |
|---|---|
| Receipt number | R000045802 |
| Scientific Title | Exploratory clinical research of Needle Length Determined Using Ultrasonic Echograms for Intramuscular Injections |
| Date of disclosure of the study information | 2020/05/07 |
| Last modified on | 2022/05/09 16:51:41 |
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Basic information
Public title
Appropriate Needle Length Determined Using Ultrasonic Echograms for Intramuscular Injections in Japanese over 50 years-old adults
Acronym
Appropriate Needle Length Determined Using Ultrasonic Echograms for Intramuscular Injections
Scientific Title
Exploratory clinical research of Needle Length Determined Using Ultrasonic Echograms for Intramuscular Injections
Scientific Title:Acronym
Appropriate Needle Length Determined Using Ultrasonic Echograms for Intramuscular Injections
Region
| Japan |
Condition
Condition
None
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study aims to assess appropriate needle length for intra-muscular (IM) injection for subjects targeted on over 50 years-old Japanese adults.
Basic objectives2
Others
Basic objectives -Others
Appropriate Needle Length Determined Using Ultrasonic Echograms for Intramuscular Injections
Trial characteristics_1
Others
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Analyze the thickness of the epidermis, subcutaneous tissue, and muscle tissues based on the different intensities of echograms. The correlation between the subcutaneous lengths and the body size is investigated.
Key secondary outcomes
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
Prevention
Type of intervention
| Other |
Interventions/Control_1
Measurement and Ulterasonic echogram of center of deltoid muscle area of upper arm
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
| 50 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
50 subjects aged 50-64 years, 50 subjects aged 65-74 years, and 60 subjects aged >75 years (20 for each group: Outpatients, Elderly needed nursing care, and Elderly on bedridden)
(1) Adults and elderly who assigned the informed consent.
(2) Elderly in a nursing home who assigned the informed consent by themselves or legal representatives.
(3) Subjects with non-serious transient illness (upper respiratory infection, etc.) and
those with chronic ailments are included when principal investigator (PI)/ sub investigator (SI) consider possible to participate the study.
(4) Japanese adults (born in Japan, and speak Japanese.)
<Reasons for settings>
(1) Based on the ethical reasons
(2) Based on the ethical reasons
(3) Excluding the influence of echogram on health condition and safety
assurance.
(4) Investigation for Japanese adults.
Key exclusion criteria
(1) Adults and elderly with some problems at the deltoid area
(2) Subjects who have some problems on measuring the circumference or Echogram judged by PI or SI.
(3) Adults and elderly with acute or chronic serious illness.
(4) Adults and elderly with some disorder at upper limb.
(5) Adults and elderly suffering from neurological or muscular illness or with the history of these illness.
(6) Subjects who are judged as not appropriate by PI or SI.
(7) Adults and elderly without informed consent by themselves or a legal representative.
Reasons for settings
(1)-(6) These items have potential influence on measuring the circumference and length of subcutaneous tissues.
(6) for safety assurance
(7) for securing the neutrality and ethical matters.
Target sample size
160
Research contact person
Name of lead principal investigator
| 1st name | Tetsuo |
| Middle name | |
| Last name | Nakayama |
Organization
Kitasato University
Division name
Omura Satoshi Memorial Institute
Zip code
108-8641
Address
5-9-1 Shirokane, Minato-ku, Tokyo
TEL
03-5791-6269
tetsuo-n@lisci.kitasato-u.ac.jp
Public contact
Name of contact person
| 1st name | Tetsuo |
| Middle name | |
| Last name | Nakayama |
Organization
Kitasato University
Division name
Omura Satoshi Memorial Institute
Zip code
108-8641
Address
5-9-1 Shirokane Minato-ku, Tokyo
TEL
03-5791-6269
Homepage URL
tetsuo-n@lisci.kitasato-u.ac.jp
Sponsor or person
Institute
Kitasato University
Omura Satoshi Memorial Institute
Institute
Department
Personal name
Funding Source
Organization
GlaxoSmithkline Biologicals
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Belgium
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethics Committee, Kitasato Institute Hospital
Address
5-9-1 ShiroKane Minato-ku, Tokyo 108-8641
Tel
03-5791-6106
kenkyu@insti.kitasato-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
医療法人社団久福会 関野病院（東京都）、志木柏町クリニック（埼玉県）
Other administrative information
Date of disclosure of the study information
| 2020 | Year | 05 | Month | 07 | 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
160
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
| 2020 | Year | 02 | Month | 14 | Day |
Date of IRB
| 2020 | Year | 08 | Month | 04 | Day |
Anticipated trial start date
| 2020 | Year | 09 | Month | 30 | Day |
Last follow-up date
| 2021 | Year | 03 | Month | 22 | Day |
Date of closure to data entry
| 2021 | Year | 04 | Month | 07 | Day |
Date trial data considered complete
| 2021 | Year | 04 | Month | 08 | Day |
Date analysis concluded
| 2021 | Year | 05 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2020 | Year | 05 | Month | 07 | Day |
Last modified on
| 2022 | Year | 05 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045802
| Research Plan | |
|---|---|
| Registered date | File name |
| 2022/05/09 | ZOSTER-077 SUPP_Study protocol_Ver1.0 14Feb20_Clean (typo revised).docx |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| 2022/05/09 | 症例報告書_Ver0.4 200.7.14 .xlsx |
| Research case data | |
|---|---|
| Registered date | File name |
| 2022/05/09 | 北里_解析結果 のコピー.xlsx |
