UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Examination of the efficacy of wide-angle lens flexible cystoscopy at the observation of bladder
Title of the study (Brief title)	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	Hiroomi Kanayama
Organization	the University of Tokushima Graduate School
Division name	Department of Urology
Address	Kuromoto-cho,Tokusima 770-8503,Japan
TEL	088-633-7159
Email	kanayama.hiroomi@tokushima-u.ac.jp

Public contact
Name of contact person	Kunihisa Yamaguchi
Organization	the University of Tokushima Graduate School
Division name	Department of Urology
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)

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

Progress
Recruitment status	Preinitiation
Date of protocol fixation	2015 Year 04 Month 27 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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/icdr_e/ctr_view.cgi?recptno=R000019387