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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000016708
Receipt No. R000019387
Scientific Title Examination of the efficacy of wide-angle lens flexible cystoscopy at the observation of bladder
Date of disclosure of the study information 2015/04/27
Last modified on 2017/03/06

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Basic information
Public title Examination of the efficacy of wide-angle lens flexible cystoscopy at the observation of bladder
Acronym Examination of the efficacy of wide-angle lens flexible cystoscopy at the observation of bladder
Scientific Title Examination of the efficacy of wide-angle lens flexible cystoscopy at the observation of bladder
Scientific Title:Acronym Examination of the efficacy of wide-angle lens flexible cystoscopy at the observation of bladder
Region
Japan

Condition
Condition bladder cancer(suspect)
Classification by specialty
Urology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 Efficacy of the intravesical observation by wide-angle lens flexible cystoscopy than a conventional cystoscopy
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2
Developmental phase Not applicable

Assessment
Primary outcomes The confirmation of the point where a wide-angle lens flexible cystoscopy is superior to a cnventional cystoscopy
Key secondary outcomes The presence or absence of problems in the intravesical observation

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Diagnosis
Type of intervention
Device,equipment
Interventions/Control_1 wide-angle lens flexible cystoscopy
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

Not applicable
Gender Male and Female
Key inclusion criteria the patients who need intravesical observation
Key exclusion criteria the patients that an agreement is notobtained
Target sample size 30

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Hiroomi Kanayama
Organization the University of Tokushima Graduate School
Division name Department of Urology
Zip code
Address Kuromoto-cho,Tokusima 770-8503,Japan
TEL 088-633-7159
Email kanayama.hiroomi@tokushima-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Kunihisa Yamaguchi
Organization the University of Tokushima Graduate School
Division name Department of Urology
Zip code
Address Kuromoto-cho,Tokusima 770-8503,Japan
TEL 088-633-7159
Homepage URL
Email yamaguchi.kunihisa@tokushima-u.ac.jp

Sponsor
Institute the University of Tokushima Graduate School
Institute
Department

Funding Source
Organization the University of Tokushima Graduate School
Organization
Division
Category of Funding Organization Other
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
2015 Year 04 Month 27 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
2015 Year 04 Month 27 Day
Date of IRB
Anticipated trial start date
2015 Year 04 Month 27 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
2015 Year 03 Month 04 Day
Last modified on
2017 Year 03 Month 06 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019387

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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