UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000035270
Receipt number R000040183
Scientific Title Assessment of urine vorticity observation in male using high-speed video-camera
Date of disclosure of the study information 2018/12/16
Last modified on 2018/12/16 15:29:23

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Basic information

Public title

Assessment of urine vorticity observation in male using high-speed video-camera

Acronym

Observation of urine vorticity

Scientific Title

Assessment of urine vorticity observation in male using high-speed video-camera

Scientific Title:Acronym

Observation of urine vorticity

Region

Japan


Condition

Condition

Healthy volunteer (male)

Classification by specialty

Urology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To confirme the vorticity of voided urine from male urethral orifice using high-speed video-camera

Basic objectives2

Others

Basic objectives -Others

It is completely mysterious whether urine stream generates vorticity or not. Herein, we attempt to visualize the vorticity of urine stream.

Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Video image and analysis using uroflowmetry

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

IPSS less than 7

Key exclusion criteria

Benign prostatic hyperplasia more than 40 cm3

Target sample size

3


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

0263372661

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

0263372661

Homepage URL


Email

minagawat@shinshu-u.ac.jp


Sponsor or person

Institute

Shinshu University School of Medicine

Institute

Department

Personal name



Funding Source

Organization

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 12 Month 03 Day

Date of IRB


Anticipated trial start date

2018 Year 12 Month 04 Day

Last follow-up date


Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

Ethical concern about images and movies


Management information

Registered date

2018 Year 12 Month 16 Day

Last modified on

2018 Year 12 Month 16 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040183


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name