UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000019679 |
|---|---|
| Receipt number | R000022741 |
| Scientific Title | Clinical research of robot-assisted laparoscopic reconstruction for urinary tract |
| Date of disclosure of the study information | 2015/11/09 |
| Last modified on | 2020/11/08 18:25:14 |
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Basic information
Public title
Clinical research of robot-assisted
laparoscopic reconstruction for urinary tract
Acronym
Clinical research of robot-assisted laparoscopic reconstruction for urinary tract
Scientific Title
Clinical research of robot-assisted
laparoscopic reconstruction for urinary tract
Scientific Title:Acronym
Clinical research of robot-assisted laparoscopic reconstruction for urinary tract
Region
| Japan |
Condition
Condition
urinary fiistula, urinary stricture, cyctocele, stress incontinece
Classification by specialty
| Urology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the safety of the use of the surgical robot (daVinci surgical system, Intuitive surgical Inc)in urinary fiistula, urinary stricture, cyctocele and stress incontinece
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
intraoperative and postoperative complications
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 urinary reconstruction
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
| 90 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
patienta who has urinary flow diturbance 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
20
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
500-8717
Address
Noishiki 4-6-1,Gifu City,Japan 5008717
TEL
058-246-1111
hesomagari333@yahoo.co.jp
Public contact
Name of contact person
| 1st name | Yoshito |
| 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
058-264-1111
Homepage URL
hesomagari333@yahoo.co.jp
Sponsor or person
Institute
Gifu Prefectural General Medical Center
Institute
Department
Personal name
Funding Source
Organization
Gifu Prefectural General Medical Center
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
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 | 09 | 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
| 2015 | Year | 10 | Month | 22 | Day |
Date of IRB
| 2015 | Year | 11 | Month | 04 | Day |
Anticipated trial start date
| 2015 | Year | 11 | Month | 10 | Day |
Last follow-up date
| 2031 | Year | 11 | Month | 11 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2015 | Year | 11 | Month | 08 | Day |
Last modified on
| 2020 | Year | 11 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022741
