UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000021211 |
|---|---|
| Receipt number | R000024458 |
| Scientific Title | Extravesical robot-assisted laparoscopic ureteral reimplantation for vesicoureteral reflux |
| Date of disclosure of the study information | 2016/02/25 |
| Last modified on | 2022/10/13 12:54:04 |
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Basic information
Public title
Extravesical robot-assisted laparoscopic ureteral reimplantation for vesicoureteral reflux
Acronym
Extravesical robot-assisted laparoscopic ureteral reimplantation
Scientific Title
Extravesical robot-assisted laparoscopic ureteral reimplantation for vesicoureteral reflux
Scientific Title:Acronym
Extravesical robot-assisted laparoscopic ureteral reimplantation
Region
| Japan |
Condition
Condition
Vesicoureteral reflux
Classification by specialty
| Urology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To certify the efficacy and safety of extravesical robot-assisted laparoscopic ureteral reimplantation, and to provide more minimally invasive surgery for patients with vesicoureteral reflux
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Resolution or improvement of vesicoureteral reflux
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
Da Vinci S surgical system
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
| 1 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) patients with vesicoureteral reflux
2) body weight of patient is above 10kg
3) written approval of patient or patient's family
Key exclusion criteria
1)severe cardiac disease
2)past open surgery with disadvantage for robotic surgery
3)uncontrolled infection
4)other congenital disorder with disadvantage for robotic surgery
5)psychiatric disorder
6)pregnant women
7)bleeding tendency
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Keiichi |
| Middle name | |
| Last name | Tozawa |
Organization
Nagoya City University Graduate School of Medical Sciences
Division name
Department of Nephro-urology
Zip code
4678601
Address
1 Kawasumi, Mizuho-cho, Mizuho-ku, Nagoya
TEL
052-853-8266
toza@med.nagoya-cu.ac.jp
Public contact
Name of contact person
| 1st name | Kentaro |
| Middle name | |
| Last name | Mizuno |
Organization
Nagoya City University Graduate School of Medical Sciences
Division name
Department of Pediatric Urology
Zip code
4678601
Address
1 Kawasumi, Mizuho-cho, Mizuho-ku, Nagoya
TEL
052-853-8266
Homepage URL
kmizuno@med.nagoya-cu.ac.jp
Sponsor or person
Institute
Nagoya City University Graduate School of Medical Sciences
Institute
Department
Personal name
Funding Source
Organization
Nagoya City University Hospital
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
Nagoya City University
Address
1 Kawasumi, Mizuho-cho, Mizuho-ku, Nagoya, Japan
Tel
052-851-5511
kmizuno@med.nagoya-cu.ac.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
名古屋市立大学病院（愛知県）
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 02 | Month | 25 | 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
Open public recruiting
Date of protocol fixation
| 2012 | Year | 04 | Month | 27 | Day |
Date of IRB
| 2022 | Year | 06 | Month | 24 | Day |
Anticipated trial start date
| 2013 | Year | 01 | Month | 17 | Day |
Last follow-up date
| 2027 | Year | 04 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2016 | Year | 02 | Month | 25 | Day |
Last modified on
| 2022 | Year | 10 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024458
