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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000041853
Receipt No. R000047777
Scientific Title The significance of 3D image analysis for preoperative evaluation of extracorporeal shock wave lithotripsy
Date of disclosure of the study information 2020/10/01
Last modified on 2020/09/20

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Basic information
Public title The significance of 3D image analysis for preoperative evaluation of extracorporeal shock wave lithotripsy
Acronym The significance of 3D image analysis for preoperative evaluation of extracorporeal shock wave lithotripsy
Scientific Title The significance of 3D image analysis for preoperative evaluation of extracorporeal shock wave lithotripsy
Scientific Title:Acronym The significance of 3D image analysis for preoperative evaluation of extracorporeal shock wave lithotripsy
Region
Japan

Condition
Condition urolithiasis
Classification by specialty
Urology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 We study the significance of 3D image analysis system for preoperative evaluation of extracorporeal shock wave lithotripsy
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Ability of information obtained in 3D image analysis to predict an efficacy of lithotripsy such as odds ratio or c-index.
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 Patients who underwent the first therapy in our institution were included.
Key exclusion criteria We excluded patients whose CT image was not available.
Target sample size 200

Research contact person
Name of lead principal investigator
1st name Ryoji
Middle name
Last name Takazawa
Organization Tokyo Metropolitan Ohtsuka Hospital
Division name Division of urology
Zip code 170-8476
Address Minami-ohtsuka 2-8-1, Toshima-ku, Tokyo, Japan
TEL 03-3941-3211
Email ryoji_takazawa@tmhp.jp

Public contact
Name of contact person
1st name Masaki
Middle name
Last name Kobayashi
Organization Tokyo Metropolitan Ohtsuka Hospital
Division name Division of urology
Zip code 170-8476
Address Minami-ohtsuka 2-8-1, Toshima-ku, Tokyo, Japan
TEL 03-3941-3211
Homepage URL
Email angel_sapporo_0329@yahoo.co.jp

Sponsor
Institute Tokyo Metropolitan Ohtsuka Hospital
Institute
Department

Funding Source
Organization Tokyo Metropolitan Ohtsuka Hospital
Organization
Division
Category of Funding Organization Local Government
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization Tokyo Metropolitan Ohtsuka hospital
Address Minami-ohtsuka 2-8-1, Toshima-ku, Tokyo, Japan
Tel 03-3941-3211
Email angel_sapporo_0329@yahoo.co.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
2020 Year 10 Month 01 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 Preinitiation
Date of protocol fixation
2014 Year 11 Month 01 Day
Date of IRB
2020 Year 09 Month 20 Day
Anticipated trial start date
2014 Year 11 Month 01 Day
Last follow-up date
2020 Year 12 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information None

Management information
Registered date
2020 Year 09 Month 20 Day
Last modified on
2020 Year 09 Month 20 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047777

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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