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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000003946
Receipt No. R000004752
Scientific Title Clinical study of Robot-assisted laparoscopic radical prostatectomy
Date of disclosure of the study information 2010/07/26
Last modified on 2014/12/15

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Basic information
Public title Clinical study of Robot-assisted laparoscopic radical prostatectomy
Acronym Robot-assisted laparoscopic radical prostatectomy
Scientific Title Clinical study of Robot-assisted laparoscopic radical prostatectomy
Scientific Title:Acronym Robot-assisted laparoscopic radical prostatectomy
Region
Japan

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

Objectives
Narrative objectives1 To evaluate the safety and effect of Robot assisted laparoscopic radical prostatectomy
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase Not applicable

Assessment
Primary outcomes Operative and postoperative complication, pathological results
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 Treatment
Type of intervention
Device,equipment Maneuver
Interventions/Control_1 Laparoscopic radical prostatectomy using da Vinci surgical system
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

Not applicable
Gender Male
Key inclusion criteria Prostate cancer patients without metastases
Key exclusion criteria Patients who do not want to participate in this study.
Patients who are judged inappropriate by the doctor.
Target sample size 10

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Masato Fujisawa
Organization Kobe University Graduate School of Medicine
Division name Division of Urology, Department of Surgery Related
Zip code
Address 7-5-1, Kusunokicho, Chuoku, Kobe, 650-0017, Japan
TEL 0783826155
Email masato@med.kobe-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Kazushi Tanaka
Organization Kobe University Graduate School of Medicine
Division name Division of Urology, Department of Surgery Related
Zip code
Address KObe
TEL 078-382-6155
Homepage URL
Email kazushi@med.kobe-u.ac.jp

Sponsor
Institute Kobe University Graduate School of Medicine
Institute
Department

Funding Source
Organization None
Organization
Division
Category of Funding Organization Self funding
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 神戸大学病院(兵庫県)

Other administrative information
Date of disclosure of the study information
2010 Year 07 Month 26 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
2010 Year 07 Month 23 Day
Date of IRB
Anticipated trial start date
2010 Year 10 Month 01 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
2010 Year 07 Month 26 Day
Last modified on
2014 Year 12 Month 15 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004752

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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