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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000020664
Receipt No. R000023812
Scientific Title Robot assisted partial nephrectomy for renal cell carcinoma
Date of disclosure of the study information 2016/01/21
Last modified on 2017/01/20

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Basic information
Public title Robot assisted partial nephrectomy for renal cell carcinoma
Acronym Robot assisted partial nephrectomy for renal cell carcinoma
Scientific Title Robot assisted partial nephrectomy for renal cell carcinoma
Scientific Title:Acronym Robot assisted partial nephrectomy for renal cell carcinoma
Region
Japan

Condition
Condition renal cell carcinoma
Classification by specialty
Urology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To assess the feasibility and safety of robot assisted partial nephrectomy for renal cell carcinoma.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes Preservation of renal function and curability of renal cell carcinoma.
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 Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Device,equipment
Interventions/Control_1 Partial nephrectomy 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
20 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria 1) cT1 renal cell carcinoma
2) cT1 renal cell carcinoma diagnosed by CT or MRI and can be resected partially.
3) cN0, cM0
4) No lung metastasis
5) Solitary tumor
6) Meet all below criteria
I. WBC greater than 3000/uL
II. Plt greater than 10000 /uL
III. AST less than 100 IU/L
IV. ALT less than 100 IU/L
V. T.Bil less than 2.0 mg/dL
7) Age greater than 20
8) Informed consent
Key exclusion criteria 1) Not applicable for partial nephrectomy
2) Metastasis
3) Other cancer
4) Undergoing renal transplantation
5) HD
6) Impossible to discontinue anti-coagulant
7) BMI over 35
8) Pregnancy
9) Psychological disorder
10) Other reason
Target sample size 10

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Norio Nonomura
Organization Osaka University Graduate School of Medicine
Division name Urology
Zip code
Address 2-2 Yamadaoka, Suita
TEL 06-6879-3531
Email nono@uro.med.osaka-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Hiroshi Kiuchi
Organization Osaka University Graduate School of Medicine
Division name Urology
Zip code
Address 2-2 Yamadaoka, Suita
TEL 06-6879-3531
Homepage URL
Email kiuchi@uro.med.osaka-u.ac.jp

Sponsor
Institute Osaka University Graduate School of Medicine
Institute
Department

Funding Source
Organization Osaka University Graduate School of Medicine
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
2016 Year 01 Month 21 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 Preinitiation
Date of protocol fixation
2016 Year 01 Month 07 Day
Date of IRB
Anticipated trial start date
2016 Year 02 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
2016 Year 01 Month 20 Day
Last modified on
2017 Year 01 Month 20 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023812

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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