UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Scattered radiation exposure to operator during ureteroscopy for stone disease: effect of protective lead curtains, a controlled trial
Title of the study (Brief title)	Scattered radiation exposure to operator during ureteroscopy for stone disease: effect of protective lead curtains, a controlled trial
Region	Japan

Condition
Condition	Stone of upper urinary tract
Classification by specialty	Urology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Reduction in total radiation dose to operator by using protective lead curtains
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Explanatory
Developmental phase	Not applicable

Assessment
Primary outcomes	Reduction of effective dose to operator between 2 groups
Key secondary outcomes	Comparison with measured dose at neck, waist outside apron and chest inside apron between 2 groups

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Cluster
Blinding	Open -no one is blinded
Control	Placebo
Stratification	NO
Dynamic allocation
Institution consideration
Blocking
Concealment	Numbered container method

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Device,equipment
Interventions/Control_1	Using protective lead curtains
Interventions/Control_2	Not using protective lead curtains
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	20 years-old <=
Age-upper limit	80 years-old >
Gender	Male and Female
Key inclusion criteria	Patients with ureteroscopic treatment for urolithiasis
Key exclusion criteria	Not positioning the lithotomy position Not performing general anesthesia
Target sample size	82

Research contact person
Name of lead principal investigator	Takaaki Inoue
Organization	Kansai Medical University, Medical center
Division name	Urology and surgery, stone center
Address	10-15,Fumizono-tyou, Moriguchi-shi, Osaka, Japan
TEL	81-06-6992-1001
Email	inouetak@hirakata.kmu.ac.jp

Public contact
Name of contact person	Takaaki Inoue
Organization	Kansai Medical University, Medical center
Division name	Urology and surgery, stone center
Address	10-15,Fumizono-tyou, Moriguchi-shi, Osaka, Japan
TEL	81-06-6992-1001
Homepage URL
Email	inouetak@hirakata.kmu.ac.jp

Sponsor
Institute	Kansai Medical University, Medical center
Institute
Department

Funding Source
Organization	None
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

Other related organizations
Co-sponsor	None
Name of secondary funｄer(s)	None

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	関西医科大学総合医療センター/Kansai Medical University, Medical center

Other administrative information
Date of disclosure of the study information	2017 Year 01 Month 19 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2016 Year 12 Month 01 Day
Anticipated trial start date	2017 Year 01 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	Published
URL releasing results
Results
Other related information

Management information
Registered date	2017 Year 01 Month 19 Day
Last modified on	2018 Year 12 Month 07 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029628