UMIN-CTR Clinical Trial

Basic information
Public title	Multicenter Study of Lens Exposure Dose for Medical staff in Hybrid Surgery
Acronym	Multicenter Study of Lens Exposure Dose for Medical staff in Hybrid Surgery
Scientific Title	Multicenter Study of Lens Exposure Dose for Medical staff in Hybrid Surgery
Scientific Title:Acronym	Multicenter Study of Lens Exposure Dose for Medical staff in Hybrid Surgery
Region	Japan

Condition
Condition	To Evaluate Lens Exposure Dose for Medical staff in Hybrid Surgery
Classification by specialty	Surgery in general Radiology Not applicable Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To Evaluate Lens Exposure Dose for Medical staff in Hybrid Surgery
Basic objectives2	Others
Basic objectives -Others	To Evaluate Lens Exposure Dose for Medical staff in Hybrid Surgery
Trial characteristics_1	Others
Trial characteristics_2	Others
Developmental phase	Not applicable

Assessment
Primary outcomes	Lens Exposure Dose for Medical staff in Hybrid Surgery
Key secondary outcomes

Base
Study type	Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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	Physicians and nurses involved in hybrid surgery
Key exclusion criteria	a medical or nursing license is suspended or revoked
Target sample size	100

Research contact person
Name of lead principal investigator	1st name Atsushi Middle name Last name Komemushi
Organization	Kansai Medical University, Medical Center
Division name	Dept. of Radiology
Zip code	570-8507
Address	10-15 Fumizono, Moriguchi, OSAKA
TEL	06-6992-1001
Email	kome64@yo.rim.or.jp

Public contact
Name of contact person	1st name Atsushi Middle name Last name Komemushi
Organization	Kansai Medical University, Medical Center
Division name	Dept. of Radiology
Zip code	570-8507
Address	10-15 Fumizono, Moriguchi, OSAKA
TEL	06-6992-1001
Homepage URL
Email	kome64@yo.rim.or.jp

Sponsor
Institute	Kansai Medical University, Medical Center
Institute
Department

Funding Source
Organization	KAKENHI 16K09026
Organization
Division
Category of Funding Organization	Japanese Governmental office
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Kansai Medical University, Medical Center
Address	10-15 Fumizono, Moriguchi, OSAKA
Tel	06-6992-1001
Email	kome64@yo.rim.or.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 07 Month 08 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	Open public recruiting
Date of protocol fixation	2019 Year 07 Month 08 Day
Date of IRB	2018 Year 05 Month 01 Day
Anticipated trial start date	2019 Year 07 Month 08 Day
Last follow-up date	2022 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	N/A

Management information
Registered date	2019 Year 07 Month 08 Day
Last modified on	2019 Year 07 Month 08 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042535