UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000010622 |
|---|---|
| Receipt number | R000012421 |
| Scientific Title | Safety and effectiveness of robotic-assisted laparoscopic radical cystectomy |
| Date of disclosure of the study information | 2013/05/01 |
| Last modified on | 2013/04/30 19:34:07 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Safety and effectiveness of robotic-assisted laparoscopic radical cystectomy
Acronym
Robotic-assisted laparoscopic radical cystectomy.
Scientific Title
Safety and effectiveness of robotic-assisted laparoscopic radical cystectomy
Scientific Title:Acronym
Robotic-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 effectiveness and safty of robotic-assisted laparoscopic radical cystectomy in patients with invasive bladder cancer.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Over all survival rate
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
Robotic-assisted laparoscopin 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
| 20 | years-old | <= |
Age-upper limit
| 80 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Patients with muscle-invasive bladder cancer.
No evidence of distant metastasis.
Age 20 years old or more, and less than 80 years old.
Patients who wish to come into compliance with protocol.
Each patient voluntarily gave written informed consent before treatment.
Key exclusion criteria
Patients with active malignant disease.
Patients who is or may be pregnant.
Patients who is breast feeding at the time of treatment.
Patients who are not suitable for laparoscopic surgery.
Patients who are not considered for being eligible to this trial by investigator.
Target sample size
5
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kanayama Hiro-omi |
Organization
tokushima university
Division name
Department of Urology
Zip code
Address
3-18-15 Kuramoto-cho Tokushima
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
tokushima university
Division name
Department of Urology
Zip code
Address
TEL
Homepage URL
Sponsor or person
Institute
tokushima university
Institute
Department
Personal name
Funding Source
Organization
Department of Urology tokushima university
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
| 2013 | Year | 05 | Month | 01 | 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
Preinitiation
Date of protocol fixation
| 2013 | Year | 04 | Month | 30 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 05 | Month | 15 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2013 | Year | 04 | Month | 30 | Day |
Last modified on
| 2013 | Year | 04 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012421
