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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000038496
Receipt No. R000043841
Scientific Title Analysis of the geometric relationship between the seat belt and the torso of vehicle occupants in various seating postures using CT images
Date of disclosure of the study information 2019/11/05
Last modified on 2019/11/05

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Basic information
Public title Analysis of the geometric relationship between the seat belt and the torso of vehicle occupants in various seating postures using CT images
Acronym Analysis of the geometric relationship between the seat belt and the torso of vehicle occupants in various seating postures using CT images
Scientific Title Analysis of the geometric relationship between the seat belt and the torso of vehicle occupants in various seating postures using CT images
Scientific Title:Acronym Analysis of the geometric relationship between the seat belt and the torso of vehicle occupants in various seating postures using CT images
Region
Japan

Condition
Condition Healthy volunteers
Classification by specialty
Radiology Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To evaluate the geometric relationship between the seat belt and torso in healthy volunteers using CT images.
Basic objectives2 Others
Basic objectives -Others To evaluate the geometric relationship between the seat belt and torso in healthy volunteers using CT images.
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Geometric relationship between the morphological parameters on images and seat belt
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Cross-over
Randomization Non-randomized
Randomization unit
Blinding Open -but assessor(s) are blinded
Control Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 3
Purpose of intervention Diagnosis
Type of intervention
Device,equipment
Interventions/Control_1 Conventional CT in a supine position
Interventions/Control_2 Upright CT in a sitting position
Interventions/Control_3 Upright CT in a standing position
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
90 years-old >
Gender Male and Female
Key inclusion criteria Healthy male or female volunteers, aged from 20 to 89, who understand the purpose of this study
Key exclusion criteria 1. Known or possible pregnancy
2. Subjects with newly developed symptoms of any diseases
3. Subjects who are not able to undergo CT in a supine, standing or sitting position
4. Claustrophobia
5. Subjects who do not provide written informed consent
Target sample size 100

Research contact person
Name of lead principal investigator
1st name Masahiro
Middle name
Last name Jinzaki
Organization Keio University School of Medicine
Division name Department of Radiology
Zip code 160-8582
Address 35 Shinanomachi, Shinjuku-ku, Tokyo, Japan
TEL 03-3353-1977(+81-3-3353-1977)
Email jinzaki@rad.med.keio.ac.jp

Public contact
Name of contact person
1st name Yoshitake
Middle name
Last name Yamada
Organization Keio University School of Medicine
Division name Department of Radiology
Zip code 160-8582
Address 35 Shinanomachi, Shinjuku-ku, Tokyo, Japan
TEL 03-3353-1977(+81-3-3353-1977)
Homepage URL
Email yamada@rad.med.keio.ac.jp

Sponsor
Institute Department of Radiology, Keio University School of Medicine
Institute
Department

Funding Source
Organization Ministry of Education, Culture, Sports, Science and Technology (MEXT)
Organization
Division
Category of Funding Organization Japanese Governmental office
Nationality of Funding Organization

Other related organizations
Co-sponsor Mechanical Systems Engineering, Graduate School of Engineering, Nagoya University
Name of secondary funder(s)

IRB Contact (For public release)
Organization Keio University School of Medicine Ethics Committee
Address 35 Shinanomachi, Shinjuku-ku, Tokyo, Japan
Tel 03-5363-3503(+81-3-5363-3503)
Email med-rinri-jimu@adst.keio.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
2019 Year 11 Month 05 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
2019 Year 09 Month 11 Day
Date of IRB
Anticipated trial start date
2019 Year 12 Month 01 Day
Last follow-up date
2022 Year 09 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2019 Year 11 Month 05 Day
Last modified on
2019 Year 11 Month 05 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043841

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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