UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	An evaluation study of efficacy and safety of robotic radical cystectomy with da Vinci Surgical System for bladder cancer
Title of the study (Brief title)	An evaluation of bladder cancer surgery with da Vinci
Region	Japan

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

Objectives
Narrative objectives1	To evaluate the efficacy and safety of robotic radical cystectomy using da Vinci Surgical System for bladder cancer
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	0ncological outcome and complication of robotic radical cystectomy
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	Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Maneuver
Interventions/Control_1	Radical cystectomy with da Vinci Surgical System (1day for surgery)
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	Patients undergoing robotic radical cystectomy with written informed consent signed and dated.
Key exclusion criteria	1) Patients who are not suitable for robotic surgery 2) Female patients who are pregnant or suspected to be pregnant. 3) Patients has psychiatric disorders that may comprise the patients ability to comply with the study. 4) Patients whose enrollement in this trial is judged to be inappropriate by the attending doctor.
Target sample size	10

Research contact person
Name of lead principal investigator	Naotaka Sakamoto
Organization	National Hospital Organization Kyushu Medical Center
Division name	Department of Urology
Address	1-8-1 Jigyohama Chuo-ku, Fukuoka 810-8563, Japan
TEL	092-852-0700
Email	sakamo@kyumed.jp

Public contact
Name of contact person	Naotaka Sakamoto
Organization	National Hospital Organization Kyushu Medical Center
Division name	Department of Urology
Address	1-8-1 Jigyohama Chuo-ku, Fukuoka 810-8563, Japan
TEL	092-852-0700
Homepage URL
Email	sakamo@kyumed.jp

Sponsor
Institute	National Hospital Organization Kyushu Medical Center
Institute
Department

Funding Source
Organization	National Hospital Organization Kyushu Medical Center
Organization
Division
Category of Funding Organization	Other
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	2017 Year 12 Month 15 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2013 Year 10 Month 04 Day
Anticipated trial start date	2013 Year 11 Month 27 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	2017 Year 12 Month 05 Day
Last modified on	2018 Year 06 Month 07 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000034564