UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000017515 |
|---|---|
| Receipt number | R000020300 |
| Scientific Title | Clinical study on safety of robot-assisted partial nephrectomy using da Vinci Si Surgical System |
| Date of disclosure of the study information | 2015/05/12 |
| Last modified on | 2018/11/13 10:02:25 |
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Basic information
Public title
Clinical study on safety of robot-assisted partial nephrectomy using da Vinci Si Surgical System
Acronym
Clinical study on safety of robot-assisted partial nephrectomy using da Vinci Si Surgical System
Scientific Title
Clinical study on safety of robot-assisted partial nephrectomy using da Vinci Si Surgical System
Scientific Title:Acronym
Clinical study on safety of robot-assisted partial nephrectomy using da Vinci Si Surgical System
Region
| Japan |
Condition
Condition
renal tumor
Classification by specialty
| Urology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To process robot-assisted partial nephrectomy using da Vinci Si Surgical System safely
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
safety of robot-assisted partial nephrectomy
Key secondary outcomes
renal ischemic time, pathologycal diagnosis of tumor, renal function during the short interval after operation, operation time, console time, blood loss, administration days.
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 |
Interventions/Control_1
operation
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
| 80 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
renal tumor suspected with malignat potential, clinical stage T1 and suitable for partial nepherectomy
Key exclusion criteria
(1)patinet who has double cancer in active
(2)patinet who can not to interupt the use of anti-coaglant drug
(3)patinet who can not fix the suitable position due to any phisical reasons
(4)patient who is not sutable for anesthesia or operation due to the exsiting conditions
(5)patinet whose operation is considerd to be difficult due to the past abdominal operation
(6)sever obesty(BMI>35)
(7)patinet with psychonurological disease or mental conditions that may interfere with this study
(8)Patient whose doctors determined as inadequate for the study
Target sample size
15
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hiroyuki Nishiyama |
Organization
Faculty of Medicine, University of Tsukuba
Division name
Department of Urology
Zip code
Address
1-1-1 Tennodai, Tsukuba, Ibaraki
TEL
029-853-3223
nishiuro@md.tsukuba.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Akira Joraku |
Organization
Faculty of Medicine, University of Tsukuba
Division name
Department of Urology
Zip code
Address
1-1-1 Tennodai, Tsukuba, Ibaraki
TEL
029-853-3223
Homepage URL
joruroa@md.tsukuba.ac.jp
Sponsor or person
Institute
University of Tsukuba
Institute
Department
Personal name
Funding Source
Organization
University of Tsukuba
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
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 05 | Month | 12 | 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
Terminated
Date of protocol fixation
| 2015 | Year | 05 | Month | 12 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 05 | Month | 15 | 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
| 2015 | Year | 05 | Month | 12 | Day |
Last modified on
| 2018 | Year | 11 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020300
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
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| Registered date | File name |
