UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000004020 |
|---|---|
| Receipt number | R000004835 |
| Scientific Title | Clinical study of Robot-assisted surgery using da Vinci S Surgical System |
| Date of disclosure of the study information | 2011/01/01 |
| Last modified on | 2012/01/31 07:08:47 |
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Basic information
Public title
Clinical study of Robot-assisted surgery using da Vinci S Surgical System
Acronym
Clinical study of Robot-assisted surgery
Scientific Title
Clinical study of Robot-assisted surgery using da Vinci S Surgical System
Scientific Title:Acronym
Clinical study of Robot-assisted surgery
Region
| Japan |
Condition
Condition
Several kinds of malignant or benign tumors in the areas of Urology, Gastrointestinal surgery, Chest surgery, and Gynecology
Classification by specialty
| Gastrointestinal surgery | Chest surgery | Obstetrics and Gynecology |
| Urology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To assess the usability and safety of endological surgery using da Vinci S Surgical System
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
overall survival, and recurrence-free survival
Key secondary outcomes
intra- and post-operative adverse events
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 | Maneuver |
Interventions/Control_1
Endological surgery using 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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) Patients with indication of endological surgery in each department
2) Patihes with will to conform with study protocol
Key exclusion criteria
1) pregnant or potentially pregnant women, nursing women
2) patients with psychiatric disease
3) contraindication of endological surgery
4) patients with severe or complicated medical conditions, not allowing participation into this protocol
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Osamu Ogawa |
Organization
Kyoto University Graduate School of Medicine
Division name
Urology
Zip code
Address
54 Kawahara-cho, Shogoin, Sakyo-ku, Kyoto
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
Kyoto University Graduate School of Medicine
Division name
Urology/Gastrointestinal Surgery/Chest Surgery/Gynecology
Zip code
Address
TEL
Homepage URL
Sponsor or person
Institute
Kyoto University Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
None
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
| 2011 | Year | 01 | 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
Open public recruiting
Date of protocol fixation
| 2010 | Year | 09 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2011 | Year | 04 | 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
| 2010 | Year | 08 | Month | 09 | Day |
Last modified on
| 2012 | Year | 01 | Month | 31 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004835
