UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000021362 |
|---|---|
| Receipt number | R000023204 |
| Scientific Title | Clinical study of robotic assisted laparoscopic partial nephrectomy using da Vinci Si surgical system |
| Date of disclosure of the study information | 2016/03/06 |
| Last modified on | 2020/09/08 16:45:26 |
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Basic information
Public title
Clinical study of robotic assisted laparoscopic partial nephrectomy using da Vinci Si surgical system
Acronym
Clinical study of robotic assisted laparoscopic partial nephrectomy using da Vinci Si surgical system
Scientific Title
Clinical study of robotic assisted laparoscopic partial nephrectomy using da Vinci Si surgical system
Scientific Title:Acronym
Clinical study of robotic assisted laparoscopic partial nephrectomy using da Vinci Si surgical system
Region
| Japan |
Condition
Condition
renal cell carcinoma
Classification by specialty
| Urology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Safety and effectiveness of robotic assisted laparoscopic partial nephrectomy using da Vinci Si surgical
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Safety and effectiveness of robotic assisted laparoscopic partial nephrectomy using da Vinci Si surgical. We will exam operative time, complication, renal function and pathology.
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
Robot-assisted partial nephrectomy by da Vinci Si 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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
clinical stage T1aN0M0
Key exclusion criteria
Patient with serious complications
Patient with active multiple primary cancer
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | Tatsuya |
| Middle name | |
| Last name | Takayama |
Organization
Jichi Medical University Hospital
Division name
Urology
Zip code
329-0498
Address
3311-1 Yakushiji Shimotsuke, Tochigi 329-0498
TEL
0285-58-7379
ttakayam@jichi.ac.jp
Public contact
Name of contact person
| 1st name | Tatsuya |
| Middle name | |
| Last name | Takayama |
Organization
Jichi Medical University Hospital
Division name
Urology
Zip code
329-0498
Address
3311-1 Yakushiji Shimotsuke, Tochigi 329-0498
TEL
0285-58-7379
Homepage URL
ttakayam@jichi.ac.jp
Sponsor or person
Institute
Department of Urology, Jichi Medical University
Institute
Department
Personal name
Funding Source
Organization
Jichi Medical 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
Jichi Medical University
Address
3311-1 Yakushiji, Shimotsuke, Tochigi 329-0498, Japan
Tel
0285-58-7576
rinri@jichi.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
自治医科大学附属病院（栃木県）
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 03 | Month | 06 | Day |
Related information
URL releasing protocol
https://upload.umin.ac.jp/cgi-open-bin/icdr/ctr_view.cgi?recptno=R000023204
Publication of results
Unpublished
Result
URL related to results and publications
https://upload.umin.ac.jp/cgi-open-bin/icdr/ctr_view.cgi?recptno=R000023204
Number of participants that the trial has enrolled
10
Results
Robot-assisted partial nephrectomy is safe and useful during 3 months followup.
Results date posted
| 2020 | Year | 09 | Month | 08 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
10 patients who underwent robot-assisted partial nephrectomy
Participant flow
Robot-assisted partial nephrectomy was performed effectively and safely in shrot-term outcome.
Adverse events
nothing paticular
Outcome measures
effective and safe in short-term outcome
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2015 | Year | 12 | Month | 01 | Day |
Date of IRB
| 2015 | Year | 12 | Month | 01 | Day |
Anticipated trial start date
| 2015 | Year | 12 | Month | 01 | Day |
Last follow-up date
| 2017 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
| 2017 | Year | 03 | Month | 21 | Day |
Other
Other related information
Management information
Registered date
| 2016 | Year | 03 | Month | 06 | Day |
Last modified on
| 2020 | Year | 09 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023204
