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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000013834
Receipt No. R000016146
Scientific Title The efficacy of fluorescence navigation system of indocyanin green in urological surgery
Date of disclosure of the study information 2014/04/28
Last modified on 2015/10/26

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Basic information
Public title The efficacy of fluorescence navigation system of indocyanin green in urological surgery
Acronym ICG Urology
Scientific Title The efficacy of fluorescence navigation system of indocyanin green in urological surgery
Scientific Title:Acronym ICG Urology
Region
Japan

Condition
Condition urological cancer
Classification by specialty
Urology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 safety
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes safety
Key secondary outcomes

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
Medicine
Interventions/Control_1 fluorescence navigation system of indocyanin green
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
85 years-old >=
Gender Male and Female
Key inclusion criteria candidate of urological surgery for urological cancer (kidney cancer, prostate cancer, bladder cancer)
WHO performance status 0/1
WBC =/under 3000/mm3
Ple =/over 100,000/mm3
Hgb =/over 8.0g/mm3
Ccr =/over 50ml/m
Bil =/under 2.0mg/dl
GOT(AST) =/under 2.5xNR
GPT(ALT) =/under 2.5xNR
Key exclusion criteria Ccr<50ml/m
Bil>2.0mg/dl
GOT(AST)>2.5xNR
GPT(ALT)>2.5xNR
allergy for iodine preparation

exclusion decided by physician
Target sample size 150

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Norihito Soga
Organization Aichi cancer center hospital
Division name Urology
Zip code
Address Kanokodenn1-1, Chikusa, Nagoya
TEL 81-52-762-6111
Email n-soga@aichi-cc.jp

Public contact
Name of contact person
1st name
Middle name
Last name Norihito Soga
Organization Aichi cancer center hospital
Division name Urology
Zip code
Address Kanokodenn1-1, Chikusa, Nagoya
TEL 81-52-762-6111
Homepage URL
Email n-soga@aichi-cc.jp

Sponsor
Institute Aichi cancer center hospital
Institute
Department

Funding Source
Organization Aichi cancer center hospital
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
2014 Year 04 Month 28 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
2014 Year 04 Month 28 Day
Date of IRB
Anticipated trial start date
2014 Year 04 Month 28 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
2014 Year 04 Month 28 Day
Last modified on
2015 Year 10 Month 26 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016146

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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