UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000002270 |
|---|---|
| Receipt number | R000002778 |
| Scientific Title | Robot- assisted radical cystectomy |
| Date of disclosure of the study information | 2009/07/30 |
| Last modified on | 2009/07/30 11:20:42 |
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Basic information
Public title
Robot- assisted radical cystectomy
Acronym
Robot- assisted radical cystectomy
Scientific Title
Robot- assisted radical cystectomy
Scientific Title:Acronym
Robot- assisted 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 | Maneuver |
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
| 80 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
80 y/o or less 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 | |
| Middle name | |
| Last name | Masaaki Tachibana |
Organization
Tokyo Medical University
Division name
Department of Urology
Zip code
Address
6-7-1, Nishishinnjuku, Shinnjuku-ku, Tokyo, Japan
TEL
03-3342-6111
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kunihiko Yoshioka |
Organization
Tokyo Medical University
Division name
Department of Urology
Zip code
Address
6-7-1, Nishishinnjuku, Shinnjuku-ku, Tokyo, Japan
TEL
03-3342-6111
Homepage URL
Sponsor or person
Institute
Tokyo Medical University
Institute
Department
Personal name
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
Address
Tel
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
| 2009 | Year | 07 | Month | 30 | 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
Date of protocol fixation
| 2009 | Year | 02 | Month | 06 | Day |
Date of IRB
Anticipated trial start date
| 2009 | Year | 02 | Month | 01 | Day |
Last follow-up date
| 2019 | Year | 02 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2009 | Year | 07 | Month | 30 | Day |
Last modified on
| 2009 | Year | 07 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002778
