UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000038496 |
|---|---|
| Receipt number | 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 | 2024/03/11 21:47:06 |
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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)
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
yamada@rad.med.keio.ac.jp
Sponsor or person
Institute
Department of Radiology, Keio University School of Medicine
Institute
Department
Personal name
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)
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
https://keio.bvits.com/rinri/Apply/project.aspx?PROJECT_ID=5212
Publication of results
Published
Result
URL related to results and publications
https://www.tandfonline.com/doi/full/10.1080/15389588.2023.2278419
Number of participants that the trial has enrolled
50
Results
The application of the submarining model to CT measurements of human subjects showed that submarining risk was lower in the order of upright, slouched, and reclined postures. In the reclined posture, the high submarining risk was attributed to a small belt-ASIS overlap and a rearward-tilted pelvis angle; whereas in the slouched posture, the risk was mostly associated with a rearward-tilted pelvis angle.
Results date posted
| 2024 | Year | 03 | Month | 11 | Day |
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
| 2019 | Year | 09 | Month | 11 | Day |
Date of IRB
| 2019 | Year | 10 | Month | 29 | Day |
Anticipated trial start date
| 2019 | Year | 12 | Month | 01 | Day |
Last follow-up date
| 2024 | Year | 02 | Month | 13 | 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
| 2024 | Year | 03 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043841
