UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Clinical study on safety of robot-assisted partial nephrectomy using da Vinci Si Surgical System
Title of the study (Brief title)	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	Hiroyuki Nishiyama
Organization	Faculty of Medicine, University of Tsukuba
Division name	Department of Urology
Address	1-1-1 Tennodai, Tsukuba, Ibaraki
TEL	029-853-3223
Email	nishiuro@md.tsukuba.ac.jp

Public contact
Name of contact person	Akira Joraku
Organization	Faculty of Medicine, University of Tsukuba
Division name	Department of Urology
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)

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

Progress
Recruitment status	Terminated
Date of protocol fixation	2015 Year 05 Month 12 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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/icdr_e/ctr_view.cgi?recptno=R000020300