臨床研究等提出・公開システム

Date of registration	Jan. 19, 2024
Last modified on	Jan. 19, 2024
Trial ID	jRCT1050230166

Scientific Title	Building a Trauma Treatment Strategy Algorithm Using Machine Learning with CT Images. Multi-institutional, backward-looking observational study (AI Trauma)
Public Title	Development of an algorithm for trauma treatment strategy using CT images. (Development of an algorithm for trauma treatment strategy using CT images.)

Contact for Scientific Queries	Name	Okada Naoki
	Affiliation	Osaka General Medical Center
	Address	3-1-56,Bandaihigashi,Sumiyoshi-ku,Osaka city OSAKA
	Telephone	+81-666921201
	E-mail	wggdilp@gmail.com
Contact for Public Queries	Name	Okada Naoki
	Affiliation	Osaka General Medical Center
	Address	3-1-56,Bandaihigashi,Sumiyoshi-ku,Osaka city OSAKA
	Telephone	+81-666921201
	E-mail	wggdilp@gmail.com

Recruitment status	Recruiting

Anticipated date of first enrollment		Dec. 27, 2021
Actual date of first enrollment		Dec. 28, 2021
Target sample size		10000
Study Type		Observational
Key inclusion & exclusion criteria	Inclusion Criteria	Select patients who meet all of the following criteria. The patient must be at least 7 years old. Patients who have undergone imaging tests such as x-ray, CT, and MRI.
	Exclusion Criteria	Patients who fall into any of the following categories will be excluded from the study. Pediatric patients under 6 years of age. Patients who are judged by the principal investigator and sub-investigators to be inappropriate as research subjects.
	Age Minimum	7age old over
	Age Maximum	No limit
	Gender	Both
Health Condition(s) or Problem(s) Studied		Trauma
Health Condition(s) Keyword		Trauma
Health Condition(s) Code		C26
Primary Outcome(s)		Fatal Trauma Detection Capability of a Machine Learning Model for Automatic Analysis of Trauma Patient Examination Images.
Secondary Outcome(s)		Comparison of predictive ability by type of trauma. Comparison of predictive ability by severity of injur.y

Primary Sponsor	Osaka General Medical Center

Secondary Sponsor

Name of Certified Review Board	Osaka General Medical Center Clinical medicine Ethics Committee
Address	3-1-56,Bandaihigashi,Sumiyoshi-ku,Osaka city OSAKA, Osaka
Telephone	+81-6-6692-1201
E-Mail	wggdilp@gmail.com
Approval Status	Approval
Date of approval	Dec. 27, 2021

Plan to share IPD	No

Countries of Recruitment（Except Japan）	America