臨床研究等提出・公開システム

Scientific Title	Study on Occupational Exposure of Echocardiography Technicians Involved in Endovascular Treatment of Structural Heart Diseases
Public Title	Study on Occupational Exposure of Operators Handling Echocardiography in Medical Procedures

Contact for Scientific Queries	Name	Nakamura Katsumasa
	Affiliation	Hamamatsu University School of Medicine
	Address	1-20-1 Handayama, Chuo-ku, Hamamatsu-shi, Shizuoka-ken
	Telephone	+81-53-435-2111
	E-mail	nakam@hama-med.ac.jp
Contact for Public Queries	Name	Yamashita Katsunori
	Affiliation	Hamamatsu University Hospital
	Address	1-20-1 Handayama, Chuo-ku, Hamamatsu-shi, Shizuoka-ken
	Telephone	+81-53-435-2111
	E-mail	07484972@hama-med.ac.jp

Recruitment status	Pending

Anticipated date of first enrollment		Feb. 27, 2024
Actual date of first enrollment
Target sample size		3
Study Type		Observational
Study Design	allocation	single arm study
	masking	open(masking not used)
	control	uncontrolled control
	assignment	factorial assignment
	purpose	other
Key inclusion & exclusion criteria	Inclusion Criteria	Three cardiologists at Hamamatsu University School of Medicine Hospital, engaged in the treatment of structural heart diseases, including two primary operators and one echocardiography technician.
	Exclusion Criteria	None
	Age Minimum	No limit
	Age Maximum	No limit
	Gender	Both
Health Condition(s) or Problem(s) Studied		None
Intervention(s)
Health Condition(s) Keyword
Intervention(s) Keyword
Health Condition(s) Code
Intervention(s) Code
Primary Outcome(s)		Exposure dose recorded by a compact dosimeter
Secondary Outcome(s)		Exposure doses measured by dosimeters attached to the anterior and lateral neck areas of the subjects. Exposure doses varied by procedural techniques and differences among the subjects.

Primary Sponsor

Source of Monetary Support / Secondary Sponsor
Secondary Sponsor

Source of Monetary Support
Secondary Sponsor

Name of Certified Review Board	Ethics Committee for Clinical Research of Hamamatsu University School of Medicine
Address	1-20-1 Handayama, Chuo-ku, Hamamatsu-shi, Shizuoka-ken, Shizuoka
Telephone	+81-53-435-2680
E-Mail	kenkyou.s@hama-med.ac.jp
Approval Status	Approval
Date of approval	Feb. 07, 2024

Plan to share IPD	No
Plan description

Secondary ID(s)
Issuing Authority

Countries of Recruitment（Except Japan）	none