UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	A multicenter study on the evaluation of eye lens doses for medical staff performing non-vascular interventional radiology procedures
Title of the study (Brief title)	A multicenter study on the evaluation of eye lens doses for medical staff performing non-vascular interventional radiology procedures
Region	Japan

Condition
Condition	Not applicable
Classification by specialty	Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Doctors and nurses in Japanese medical facilities wear protective glasses during non-vascular endoscopic interventional radiology procedures. After taking informed consent, they equip the protective glasses with small dosimeters and measure their eye lens doses during the procedures to determine the actual state of eye lens dosage for such doctors and nurses in Japan.
Basic objectives2	Safety
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	The doctors and nurses engaged in non-vascular endoscopic interventional radiology procedures wear protective glasses equipped with small dosimeters for a month, and their eye lens doses are obtained from the dosimeters after the experimental period. The eye lens doses are evaluated by converting monthly values into annual values.
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Educational,Counseling,Training
Type of intervention	Device,equipment
Interventions/Control_1	Attendees wear protective glasses equipped with small dosimeters during non-vascular endoscopic interventional radiology procedures for a month.
Interventions/Control_2
Interventions/Control_3
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	Not applicable
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	Doctors or nurses engaged in non-vascular endoscopic interventional radiology procedures
Key exclusion criteria	None
Target sample size	100

Research contact person
Name of lead principal investigator	Kosuke Matsubara
Organization	Institute of Medical, Pharmaceutical and Health Sciences, Kanazawa University
Division name	Quantum Medical Technology
Address	5-11-80 Kodatsuno, Kanazawa, Ishikawa
TEL	076-265-2500
Email	matsuk@mhs.mp.kanazawa-u.ac.jp

Public contact
Name of contact person	Kosuke Matsubara
Organization	Institute of Medical, Pharmaceutical and Health Sciences, Kanazawa University
Division name	Quantum Medical Technology
Address	5-11-80 Kodatsuno, Kanazawa, Ishikawa
TEL	076-265-2500
Homepage URL
Email	matsuk@mhs.mp.kanazawa-u.ac.jp

Sponsor
Institute	Institute of Medical, Pharmaceutical and Health Sciences, Kanazawa University
Institute
Department

Funding Source
Organization	Japanese Society of Radiological Technology
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization	Japan

Other related organizations
Co-sponsor	National Institute of Radiological Sciences, Asahi Hospital, Fujita Health University, Hamamatsu University Hospital, Kanazawa University Hospital, JCHO Hokkaido Hospital, Nagase Landauer Ltd.
Name of secondary funｄer(s)

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	2014 Year 08 Month 25 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2014 Year 07 Month 24 Day
Anticipated trial start date	2014 Year 09 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2014 Year 08 Month 25 Day
Last modified on	2017 Year 05 Month 15 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000017385