UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000003667 |
|---|---|
| Receipt number | R000004444 |
| Scientific Title | Determination of feasibility and safety in Robot-assisted surgery using da Vinci S Surgical System for digestive disease of malignancy. |
| Date of disclosure of the study information | 2010/05/26 |
| Last modified on | 2013/11/26 16:14:58 |
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Basic information
Public title
Determination of feasibility and safety in Robot-assisted surgery using da Vinci S Surgical System for digestive disease of malignancy.
Acronym
Feasibility and safety of Robot-assisted surgery for digestive disease of malignancy.
Scientific Title
Determination of feasibility and safety in Robot-assisted surgery using da Vinci S Surgical System for digestive disease of malignancy.
Scientific Title:Acronym
Feasibility and safety of Robot-assisted surgery for digestive disease of malignancy.
Region
| Japan |
Condition
Condition
All malignant digestive diseases for which laparoscopic surgery was applicable
Classification by specialty
| Gastrointestinal surgery | Hepato-biliary-pancreatic surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the feasibility and safety of less invasive surgery using da Vinci S Surgical system.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Phase I
Assessment
Primary outcomes
Oncological adequacy and frequency of adverse events
Key secondary outcomes
Frequency of intraoprative and postoperative severe complications (mortality, conversion to laparoscopic or open surgery and reoperation)
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 da Vinci S surgical System for surgery of digestive disease of malignancy.
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 malignant digestive disease which is applicable for endoscopic surgery.
(2) Written informed consent is essential.
Key exclusion criteria
(1)Patients with active multiple cancers.
(2)Woman in pregnancy (or woman of child bearing potential) and breast-feeding woman.
(3)Patients with psychiatric disease.
(4)Cases which is unsuitable for laparoscopic or thoracoscopic surgery.
(5)Cases which the investigators think inadequate to this study.
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hirokazu Noshiro |
Organization
Saga University
Division name
Surgery
Zip code
Address
5-1-1 Nabeshima, Saga, Japan
TEL
0952-34-2349
noshiro@cc.saga-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hirokazu Noshiro |
Organization
Saga University
Division name
Surgery
Zip code
Address
5-1-1 Nabeshima, Saga, Japan
TEL
0952-34-2349
Homepage URL
noshiro@cc.saga-u.ac.jp
Sponsor or person
Institute
Saga University
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
None
Name of secondary funder(s)
None
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
佐賀大学医学部附属病院(佐賀県)
Other administrative information
Date of disclosure of the study information
| 2010 | Year | 05 | Month | 26 | 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 | 02 | Month | 10 | Day |
Date of IRB
Anticipated trial start date
| 2010 | Year | 03 | Month | 01 | Day |
Last follow-up date
| 2016 | Year | 12 | Month | 01 | Day |
Date of closure to data entry
| 2016 | Year | 12 | Month | 01 | Day |
Date trial data considered complete
| 2016 | Year | 12 | Month | 01 | Day |
Date analysis concluded
| 2016 | Year | 12 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2010 | Year | 05 | Month | 26 | Day |
Last modified on
| 2013 | Year | 11 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004444
