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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000043789
Receipt No. R000049988
Scientific Title Development of precise nerve sparing robot assisted laparoscopic radical prostatectomy using ICG navigation system
Date of disclosure of the study information 2021/04/01
Last modified on 2021/03/30

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Basic information
Public title Development of precise nerve sparing robot assisted laparoscopic radical prostatectomy using ICG navigation system
Acronym Development of precise NS-RARP using ICG
Scientific Title Development of precise nerve sparing robot assisted laparoscopic radical prostatectomy using ICG navigation system
Scientific Title:Acronym Development of precise NS-RARP using ICG
Region
Japan

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

Objectives
Narrative objectives1 The aim of the present study is whether venous injection of ICG could allow for the precise nerve sparing robot-assisted laparoscopic radical prostatectomy.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes The number of nNOS positive cells between the ICG group and non-ICG group
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Non-randomized
Randomization unit
Blinding Open -but assessor(s) are blinded
Control Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 intravenous injection of ICG
Interventions/Control_2 Sham
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
40 years-old <=
Age-upper limit
80 years-old >=
Gender Male
Key inclusion criteria the patients who would undergo robot assisted laparoscopic radical prostatectomy (RARP) in our hospital
Key exclusion criteria 1. the patients with allergic reaction of ICG
2. the patients for whom androgen deprivation therapy was performed
Target sample size 60

Research contact person
Name of lead principal investigator
1st name Nobuhiro
Middle name
Last name Haga
Organization Fukuoka University, Faculty of Medicine
Division name Department of Urology
Zip code 814-0180
Address 45-1, 7-chome Nanakuma, Jonan-ku
TEL 0928011011
Email urology@fukuoka-u.ac.jp

Public contact
Name of contact person
1st name Nobuhiro
Middle name
Last name Haga
Organization Fukuoka University, Faculty of Medicine
Division name Department of Urology
Zip code 814-0180
Address 45-1, 7-chome Nanakuma, Jonan-ku
TEL 0928011011
Homepage URL
Email urology@fukuoka-u.ac.jp

Sponsor
Institute Fukuoka University, Faculty of Medicine
Institute
Department

Funding Source
Organization Fukuoka University, Faculty of Medicine
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 Fukuoka University, Faculty of Medicine
Address 45-1, 7-chome Nanakuma, Jonan-ku
Tel 0928011011
Email urology@fukuoka-u.ac.jp

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
2021 Year 04 Month 01 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
2021 Year 03 Month 24 Day
Date of IRB
Anticipated trial start date
2021 Year 04 Month 01 Day
Last follow-up date
2026 Year 01 Month 17 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2021 Year 03 Month 30 Day
Last modified on
2021 Year 03 Month 30 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049988

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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