UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000025753
Receipt No. R000029628
Scientific Title Scattered radiation exposure to operator during ureteroscopy for stone disease: effect of protective lead curtains, a controlled trial
Date of disclosure of the study information 2017/01/19
Last modified on 2018/12/07

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information
Public title Scattered radiation exposure to operator during ureteroscopy for stone disease: effect of protective lead curtains, a controlled trial
Acronym Scattered radiation exposure to operator during ureteroscopy for stone disease: effect of protective lead curtains, a controlled trial
Scientific Title Scattered radiation exposure to operator during ureteroscopy for stone disease: effect of protective lead curtains, a controlled trial
Scientific Title:Acronym 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
1st name
Middle name
Last name Takaaki Inoue
Organization Kansai Medical University, Medical center
Division name Urology and surgery, stone center
Zip code
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
1st name
Middle name
Last name Takaaki Inoue
Organization Kansai Medical University, Medical center
Division name Urology and surgery, stone center
Zip code
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

IRB Contact (For public release)
Organization
Address
Tel
Email

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

Related information
URL releasing protocol
Publication of results Published

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
2016 Year 12 Month 01 Day
Date of IRB
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

Other
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

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.