UMIN-CTR Clinical Trial

Basic information
Public title	Clinical research of robot-assisted laparoscopic radical cystectomy
Acronym	Clinical research of robot-assisted laparoscopic radical cystectomy
Scientific Title	Clinical research of robot-assisted laparoscopic radical cystectomy
Scientific Title:Acronym	Clinical research of robot-assisted laparoscopic radical cystectomy
Region	Japan

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

Objectives
Narrative objectives1	To evaluate the safety of the use of the surgical robot (daVinci surgical system, Intuitive surgical Inc)in radical cystectomy
Basic objectives2	Safety
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	intraoperative and postoperative complications, pathological results
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	Device,equipment
Interventions/Control_1	the use of daVinci surgical system for radical cystectomy
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	Not applicable
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	patients with histologically confirmed bladder cancer which is thought to be hard to be resected or cured by endoscopically.
Key exclusion criteria	patients who don't want to participate in this study. Patients who are unable to tolerate general anesthesia.
Target sample size	50

Research contact person
Name of lead principal investigator	1st name yoshito Middle name Last name Takahashi
Organization	Gifu Prefectural General Medical Center
Division name	Department of urology
Zip code	5008717
Address	Noishiki 4-6-1,Gifu City,Japan 5008717
TEL	058-246-1111
Email	gi.ta.to8424@gifu-hp.jp

Public contact
Name of contact person	1st name Ypshito Middle name Last name Takahashi
Organization	Gifu Prefectural General Medical Center
Division name	Department of urology
Zip code	500-8717
Address	Noishiki 4-6-1,Gifu City,Japan 5008717
TEL	058-246-1111
Homepage URL
Email	gi.ta.to8424@gifu-hp.jp

Sponsor
Institute	Gifu Prefectural General Medical Center
Institute
Department

Funding Source
Organization	none
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	Gifu Prefectural General Medical Center
Address	Noishiki 4-6-1,Gifu City,Japan 5008717
Tel	058-246-1111
Email	hesomagari333@yahoo.co.jp

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 11 Month 01 Day

Related information
URL releasing protocol
Publication of results	Partially published

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	Open public recruiting
Date of protocol fixation	2013 Year 02 Month 26 Day
Date of IRB	2013 Year 12 Month 15 Day
Anticipated trial start date	2015 Year 11 Month 01 Day
Last follow-up date	2026 Year 12 Month 31 Day
Date of closure to data entry	2027 Year 12 Month 31 Day
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2015 Year 10 Month 29 Day
Last modified on	2020 Year 11 Month 08 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000022612