UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000043789 |
|---|---|
| Receipt number | 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 | 2021/10/11 13:26:02 |
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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
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
urology@fukuoka-u.ac.jp
Sponsor or person
Institute
Fukuoka University, Faculty of Medicine
Institute
Department
Personal name
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
fumed-ethics@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 | 10 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049988
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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