UMIN-CTR Clinical Trial

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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