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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000035269
Receipt No. R000040182
Scientific Title Flow dynamic assessment of lower urinary tract using vector flow mapping
Date of disclosure of the study information 2018/12/16
Last modified on 2018/12/16

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Basic information
Public title Flow dynamic assessment of lower urinary tract using vector flow mapping
Acronym Flow dynamic assessment of LUT using VFM
Scientific Title Flow dynamic assessment of lower urinary tract using vector flow mapping
Scientific Title:Acronym Flow dynamic assessment of LUT using VFM
Region
Japan

Condition
Condition Healthy volunteer
Classification by specialty
Urology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To establish methodology to evaluate fluid dynamic assessment of LUT
Basic objectives2 Others
Basic objectives -Others Flow dynamical assessment of urine steam has not established yet. Herein ,we attempt to visualize urine flow in urinary bladder using VFM.
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Visualization of urine stream in urinary bladder
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
20 years-old <=
Age-upper limit
80 years-old >
Gender Male
Key inclusion criteria Less than 7 of IPSS
Key exclusion criteria Benign prostate hyperplasia more than 40 cm3
Target sample size 2

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Tomonori Minagawa
Organization Shinshu University, School of Medicine
Division name Urology
Zip code
Address 3-1-1 Asahi, Matsumoto city, Nagano, Japan
TEL 0263-37-2661
Email minagawat@shinshu-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Tomonori Minagawa
Organization Shinshu University, School of Medicine
Division name Urology
Zip code
Address 3-1-1 Asahi, Matsumoto city, Nagano, Japan
TEL 0263-37-2661
Homepage URL
Email minagawat@shinshu-u.ac.jp

Sponsor
Institute Shinshu University
Institute
Department

Funding Source
Organization Department of Urology, Shinshu University School of Medicine
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

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

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

Other administrative information
Date of disclosure of the study information
2018 Year 12 Month 16 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
2018 Year 09 Month 01 Day
Date of IRB
Anticipated trial start date
2018 Year 09 Month 05 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Analysis of image data obtained by ultrasonography

Management information
Registered date
2018 Year 12 Month 16 Day
Last modified on
2018 Year 12 Month 16 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040182

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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