UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Clinical trial on the efficacy and safety of robot assisted laparoscopic partial nephrectomy using Davinci surgical system
Title of the study (Brief title)	Clinical trial on the efficacy and safety of robot assisted laparoscopic partial nephrectomy using Davinci surgical system
Region	Japan

Condition
Condition	renal tumor
Classification by specialty	Urology
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	Clinical trial on the efficacy and safety of robot assisted laparoscopic partial nephrectomy using Davinci surgical system
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Efficacy and safety of robot assisted laparoscopic partial nephrectomy (surgical margine negative,WIT<25min,no blood transfusion,no complication)
Key secondary outcomes	operative time, complication, pathology, prognosis

In outcomes field, the entry of just a few words such as "safety" or "efficiency" will not be accepted. Specify the name of outcome measures, including the time when you plan to measure. Usually, only one primary outcome is accepted. Write the other outcomes in "secondary outcomes" field.

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	Maneuver
Interventions/Control_1	patient of renal cellcarcinoma
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

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

Eligibility
Age-lower limit	20 years-old <=
Age-upper limit	80 years-old >
Gender	Male and Female
Key inclusion criteria	clinical stage T1aN0M0
Key exclusion criteria	performance status 2 ASA 4
Target sample size	30

Research contact person
Name of lead principal investigator	Tadashi Matsuda
Organization	Kansai medical university Hirakata hospital
Division name	urology
Address	2-3-1 hirakata osaka
TEL	072-804-0101
Email	matsudat@takii.kmu.ac.jp

Public contact
Name of contact person	Motohiko Sugi
Organization	Kansai medical university Hirakata hospital
Division name	urology
Address	2-3-1 hirakata osaka
TEL	072-804-0101
Homepage URL
Email	sugim@takii.kmu.ac.jp

Sponsor
Institute	the department of urology, kansai medical university
Institute
Department

Sponsor means an organization that is responsible for plan, deployment and report of the research including funding management. It doesn't mean funding agency". Therefore, all clinical trial should have the one.

Funding Source
Organization	the department of urology, kansai medical university
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

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	関西医科大学　枚方病院

Other administrative information
Date of disclosure of the study information	2014 Year 04 Month 23 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2014 Year 04 Month 23 Day
Anticipated trial start date	2014 Year 05 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2014 Year 04 Month 22 Day
Last modified on	2016 Year 05 Month 31 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015290