UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000011317 |
|---|---|
| Receipt number | 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 14:48:06 |
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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
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
shorie@juntendo.ac.jp
Sponsor or person
Institute
Juntendo University, School of Medicine
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013263
