UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000010815 |
|---|---|
| Receipt number | R000012660 |
| Scientific Title | Evaluation of efficacy and safety of robot-assisted laparoscopic partial nephrectomy using Da Vinci S surgical system |
| Date of disclosure of the study information | 2013/05/27 |
| Last modified on | 2013/05/27 20:29:35 |
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Basic information
Public title
Evaluation of efficacy and safety of robot-assisted laparoscopic partial nephrectomy using Da Vinci S surgical system
Acronym
Clinical evaluation of robot-assisted laparoscopic partial nephrectomy
Scientific Title
Evaluation of efficacy and safety of robot-assisted laparoscopic partial nephrectomy using Da Vinci S surgical system
Scientific Title:Acronym
Clinical evaluation of robot-assisted laparoscopic partial nephrectomy
Region
| Japan |
Condition
Condition
Renal tumors
Classification by specialty
| Urology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the clinical efficacy and safety of robot-assisted laparoscopic partial nephrectomy
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
operation time, peri-operative complication, renal ischemic time, postoperative renal function, oncological outcome
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
Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
Robot-assisted laparoscopic surgery using DaVince 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
| 20 | years-old | <= |
Age-upper limit
| 90 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1) Renal tumors 4cm or less, 2) exophytic tumors larger than 4cm
Key exclusion criteria
1) Patients with pT3a or those with metastases to lymph nodes or distant organs, 2) patients suspected to have severe intraabdominal adhesion due to multiple previous surgery, 3) patients for whom the surgery is not indicated, 4) Patients who are not considered eligible for this trial by a trial administrator.
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kazunari Tanabe |
Organization
Tokyo Women's Medical University
Division name
Urology
Zip code
Address
8-1 Kawada-sho, Shinjuku-ku, Tokyo 162-8666, Japan
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
Tokyo Women's Medical University
Division name
Urology
Zip code
Address
TEL
Homepage URL
Sponsor or person
Institute
Department of Urology, Tokyo Women's Medical University
Institute
Department
Personal name
Funding Source
Organization
Department of Urology, Tokyo Women's Medical 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 | 27 | 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
| 2013 | Year | 01 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 01 | 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
| 2013 | Year | 05 | Month | 27 | Day |
Last modified on
| 2013 | Year | 05 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012660
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
