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Name:
UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000017515
Receipt No. 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

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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
Email 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
Email joruroa@md.tsukuba.ac.jp

Sponsor
Institute University of Tsukuba
Institute
Department

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
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

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
URL(English) https://upload.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
Registered date File name


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