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UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000011317
Receipt No. R000013263
Scientific Title Clinical Study for Robot assisted laparoscopic urologic surgery with da Vinci Si Surgical System
Date of disclosure of the study information 2013/07/30
Last modified on 2013/07/30

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Basic information
Public title Clinical Study for Robot assisted laparoscopic urologic surgery with da Vinci Si Surgical System
Acronym Clinical Study for Robot assisted laparoscopic urologic surgery with da Vinci Si Surgical System
Scientific Title Clinical Study for Robot assisted laparoscopic urologic surgery with da Vinci Si Surgical System
Scientific Title:Acronym Clinical Study for Robot assisted laparoscopic urologic surgery with da Vinci Si Surgical System
Region
Japan

Condition
Condition urological cancer, kidney,ureter and urinary bladder
(uretero-pyelo junction stenosis)
Classification by specialty
Urology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 Study concerning safety on operation
in minimal stress with using da Vinci Si Surgical System in robot assisted laparoscopic urologic surgery.
Basic objectives2 Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase Not applicable

Assessment
Primary outcomes Incidence of adverse event related suergry during and post operation
Key secondary outcomes Duration of disease free survival and overall survival postoperative within 5 years

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
Maneuver
Interventions/Control_1 Patients :
indicated urologic laparoscopic
surgery,for malignant tumor of
kidney,ureter and bladder,
in addition uretero-pyelo junction
stricture (pyeloplasty)
method : robot assisted laparoscopic surgery using da Vinci Si 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

Not applicable
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria 1.Patients with
kidney,ureter,bladder cancer
and hydronephrosis due to
uretero-pyelo junction stricture,
those indicated laparoscopic
surgery,

2.Written consent form for this study
from patient.
Key exclusion criteria 1.Female patient under pregnancy or nursing.
2 Mental disease or uncontrolled status
Target sample size 100

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Shigeo Horie
Organization Juntendo University, School of Medicine
Division name Department of Urology
Zip code
Address Hongo 2-1-1 Bunkyo-ward Tokyo Japan
TEL 03-3815-3873
Email

Public contact
Name of contact person
1st name
Middle name
Last name Shigeo Horie
Organization Juntendo University, School of Medicine
Division name Department of Urology
Zip code
Address Hongo 2-1-1 Bunkyo-ward Tokyo Japan
TEL 03-3815-3873
Homepage URL
Email shorie@juntendo.ac.jp

Sponsor
Institute Juntendo University, 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 順天堂大学医学部附属病院(東京)/Juntendo University Hospital(Tokyo)

Other administrative information
Date of disclosure of the study information
2013 Year 07 Month 30 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 Open public recruiting
Date of protocol fixation
2013 Year 07 Month 25 Day
Date of IRB
Anticipated trial start date
2013 Year 07 Month 25 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
2013 Year 07 Month 30 Day
Last modified on
2013 Year 07 Month 30 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013263

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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