UMIN-CTR Clinical Trial

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
Email	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
Email	tetsuo-n@lisci.kitasato-u.ac.jp

Sponsor
Institute	Kitasato University Omura Satoshi Memorial Institute
Institute
Department

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
Email	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

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
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	Open public recruiting
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 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2020 Year 05 Month 07 Day
Last modified on	2021 Year 01 Month 06 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045802

Research Plan
Registered date	File name

Research case data specifications
Registered date	File name

Research case data
Registered date	File name

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