UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000011281 |
|---|---|
| Receipt number | R000012035 |
| Scientific Title | Phase II study of da Vinci S/Si Surgical System assisted radical prostatectomy |
| Date of disclosure of the study information | 2013/12/10 |
| Last modified on | 2023/08/03 11:05:38 |
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Basic information
Public title
Phase II study of da Vinci S/Si Surgical System assisted radical prostatectomy
Acronym
Robot assisted radical prostatectomy
Scientific Title
Phase II study of da Vinci S/Si Surgical System assisted radical prostatectomy
Scientific Title:Acronym
Robot assisted radical prostatectomy
Region
| Japan |
Condition
Condition
NCCN low to high risk prostate cancer
Classification by specialty
| Urology | Adult |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Verification of surgical outcome by robot assisted radical prostatectomy
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Phase II
Assessment
Primary outcomes
Rate of vesico-urethral leakage
Key secondary outcomes
Rate of the adverse effect by Clavien-Dindo classification Grade II or more
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
Treatment
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
| Not applicable |
Age-upper limit
| 75 | years-old | >= |
Gender
Male
Key inclusion criteria
NCCN risk: Low to high risk
Key exclusion criteria
Post open pelvic-laparotomy cases
Target sample size
250
Research contact person
Name of lead principal investigator
| 1st name | Hiroyuki |
| Middle name | |
| Last name | Fujimoto |
Organization
National Cancer Center Hospital
Division name
Urology Division
Zip code
104-0045
Address
Chu-oku Tukiji 5-1-1
TEL
03-3542-2511
hfujimot@ncc.go.jp
Public contact
Name of contact person
| 1st name | Hiroyuki |
| Middle name | |
| Last name | Fujimoto |
Organization
National Cancer Center Hospital
Division name
Urology Division
Zip code
104-0045
Address
Chu-oku Tukiji 5-1-1
TEL
03-3542-2511
Homepage URL
hfujimot@ncc.go.jp
Sponsor or person
Institute
National Cancer Center Hospital
Institute
Department
Personal name
Funding Source
Organization
MHLW(Japan)
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
National Cancer Center
Address
Chu-oku Tukiji 5-1-1
Tel
03-3542-2511
hfujimot@ncc.go.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
国立がん研究センター中央病院(東京)
Other administrative information
Date of disclosure of the study information
| 2013 | Year | 12 | Month | 10 | 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
Completed
Date of protocol fixation
| 2012 | Year | 08 | Month | 07 | Day |
Date of IRB
| 2019 | Year | 06 | Month | 05 | Day |
Anticipated trial start date
| 2012 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2019 | Year | 02 | Month | 01 | Day |
Date of closure to data entry
| 2019 | Year | 02 | Month | 01 | Day |
Date trial data considered complete
| 2019 | Year | 02 | Month | 01 | Day |
Date analysis concluded
| 2019 | Year | 10 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2013 | Year | 07 | Month | 26 | Day |
Last modified on
| 2023 | Year | 08 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012035
