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)

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 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)

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

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


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name