UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000014941 |
|---|---|
| Receipt number | R000017385 |
| Scientific Title | A multicenter study on the evaluation of eye lens doses for medical staff performing non-vascular interventional radiology procedures |
| Date of disclosure of the study information | 2014/08/25 |
| Last modified on | 2017/05/15 18:01:06 |
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Basic information
Public title
A multicenter study on the evaluation of eye lens doses for medical staff performing non-vascular interventional radiology procedures
Acronym
A multicenter study on the evaluation of eye lens doses for medical staff performing non-vascular interventional radiology procedures
Scientific Title
A multicenter study on the evaluation of eye lens doses for medical staff performing non-vascular interventional radiology procedures
Scientific Title:Acronym
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
| 1st name | |
| Middle name | |
| Last name | Kosuke Matsubara |
Organization
Institute of Medical, Pharmaceutical and Health Sciences, Kanazawa University
Division name
Quantum Medical Technology
Zip code
Address
5-11-80 Kodatsuno, Kanazawa, Ishikawa
TEL
076-265-2500
matsuk@mhs.mp.kanazawa-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kosuke Matsubara |
Organization
Institute of Medical, Pharmaceutical and Health Sciences, Kanazawa University
Division name
Quantum Medical Technology
Zip code
Address
5-11-80 Kodatsuno, Kanazawa, Ishikawa
TEL
076-265-2500
Homepage URL
matsuk@mhs.mp.kanazawa-u.ac.jp
Sponsor or person
Institute
Institute of Medical, Pharmaceutical and Health Sciences, Kanazawa University
Institute
Department
Personal name
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)
IRB Contact (For public release)
Organization
Address
Tel
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 |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
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
| 2014 | Year | 07 | Month | 24 | Day |
Date of IRB
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
Other
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017385
