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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000023545
Receipt No. R000027118
Scientific Title Robot-Assisted Laparoscopic Parcial Nephrectomy for kidney cancer
Date of disclosure of the study information 2016/08/08
Last modified on 2016/08/08

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Basic information
Public title Robot-Assisted Laparoscopic Parcial Nephrectomy for kidney cancer
Acronym Robot-Assisted Laparoscopic Parcial Nephrectomy for kidney cancer
Scientific Title Robot-Assisted Laparoscopic Parcial Nephrectomy for kidney cancer
Scientific Title:Acronym Robot-Assisted Laparoscopic Parcial Nephrectomy for kidney cancer
Region
Japan

Condition
Condition kidney cancer
Classification by specialty
Urology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 This study aims to analyze the outcome and safety of Robot-Assisted Laparoscopic Partial Nephrectomy for patients with small renal cancer.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Warm Ischemia Time
Key secondary outcomes 2-year recurrence-free survival rate
Complication rates
length of stay in hospital

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 Surgical Robot (Da Vinci Si)
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) diagnosed as kidney cancer with indication for partial nephrectomy.
(2) aged 20 or over.
(3) signed written informed consent.
Key exclusion criteria (1) severe mental disorder
(2) below age 20 years.
(3) severe respiratory disorder.
(4) hemorrhagic diathesis.
(5) severe diabetes mellitus.
(6) severe infectious disease
(7) judged as inappropriate by investigators.
Target sample size 6

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yoshiaki Kawano
Organization Faculty of Life Sciences, Kumamoto University
Division name Department of Urology
Zip code
Address 1-1-1 Honjo, Chuo-ku, Kumamoto
TEL 096-373-5240
Email urology@kumamoto-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Yoshiaki Kawano
Organization Faculty of Life Sciences, Kumamoto University
Division name Department of Urology
Zip code
Address 1-1-1 Honjo, Chuo-ku, Kumamoto
TEL 096-373-5240
Homepage URL
Email urology@kumamoto-u.ac.jp

Sponsor
Institute Kumamoto University
Institute
Department

Funding Source
Organization Kumamoto University
Organization
Division
Category of Funding Organization Other
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 熊本大学医学部附属病院(熊本県)

Other administrative information
Date of disclosure of the study information
2016 Year 08 Month 08 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 No longer recruiting
Date of protocol fixation
2014 Year 03 Month 03 Day
Date of IRB
Anticipated trial start date
2014 Year 03 Month 03 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Since 2015/10/01, lead principal investigator has been changed as below:

Masatoshi Eto -> Yoshiaki Kawano

Since 2015/09/02, Planned total case number has been changed as below:

5 cases -> 6 cases

Management information
Registered date
2016 Year 08 Month 08 Day
Last modified on
2016 Year 08 Month 08 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027118

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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