UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000024804 |
|---|---|
| Receipt number | R000028541 |
| Scientific Title | Clinical study for rabot-assisted laparoscopic radical cystectomy |
| Date of disclosure of the study information | 2016/12/01 |
| Last modified on | 2016/11/11 15:54:37 |
* 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
Clinical study for rabot-assisted laparoscopic radical cystectomy
Acronym
Clinical study for RARC
Scientific Title
Clinical study for rabot-assisted laparoscopic radical cystectomy
Scientific Title:Acronym
Clinical study for RARC
Region
| Japan |
Condition
Condition
bladder cancer
Classification by specialty
| Urology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The objective of this study is to assess the ustility of robot-assisted laparoscopic radical cystectomy for patients with nonmetastatic muscle-invasive bladder cancer.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Perioperative adverse events
Key secondary outcomes
operative time, blood loss
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
Patinets with nonmetastatic muscle invasive bladder cancer, who take part in this study, will be treated with robot-assisted laparoscopic 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 bladder cancer
Patients who agree to receive robot-assisted laparoscopic radical cystectomy
(Prior to start the study, wrriten informed consent will be required for all participants)
Key exclusion criteria
1. Patients with active double cancers
2. Patients possibly in pregnant
3. Patients who are not optimal candidates for laparoscopic surgery
4. Patients who are not candidates for this study
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hideaki Miyake |
Organization
Hamamatsu University School of Medicine
Division name
Department of Urology
Zip code
Address
1-20-1 Handayama, Higashi-Ku, Hamamatsu 431-3192, Japan
TEL
0534352306
hmiyake@hama-med.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hideaki Miyake |
Organization
Hamamatsu University School of Medicine
Division name
Department of Urology
Zip code
Address
1-20-1 Handayama, Higashi-Ku, Hamamatsu 431-3192, Japan
TEL
0534352306
Homepage URL
hmiyake@hama-med.ac.jp
Sponsor or person
Institute
Hamamatsu University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Hamamatsu University School of Medicine
Organization
Division
Category of Funding Organization
Other
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
| 2016 | Year | 12 | 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
Date of protocol fixation
| 2016 | Year | 10 | Month | 11 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 12 | Month | 01 | 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
| 2016 | Year | 11 | Month | 11 | Day |
Last modified on
| 2016 | Year | 11 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028541
