UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000013280 |
|---|---|
| Receipt number | R000015486 |
| Scientific Title | The investigation of the feasibility of robotic surgery for gastric cancer using da Vinci S Surgical System |
| Date of disclosure of the study information | 2014/03/01 |
| Last modified on | 2019/09/03 17:51:10 |
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Basic information
Public title
The investigation of the feasibility of robotic surgery for gastric cancer using da Vinci S Surgical System
Acronym
The investigation of robotic surgery for gastric cancer
Scientific Title
The investigation of the feasibility of robotic surgery for gastric cancer using da Vinci S Surgical System
Scientific Title:Acronym
The investigation of robotic surgery for gastric cancer
Region
| Japan |
Condition
Condition
gastric cancer
Classification by specialty
| Gastrointestinal surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To investigate the safety and efficacy of robotic surgery for laparoscopic gastrectomy.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The rate of postoperative complication
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
operation 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
| 20 | years-old | <= |
Age-upper limit
| 75 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
cases with gastric cancer for laparoscopic surgery
Key exclusion criteria
the patients with sever condition
Target sample size
15
Research contact person
Name of lead principal investigator
| 1st name | Masafumi |
| Middle name | |
| Last name | Nakamura |
Organization
Kyushu university
Division name
Department of surgery and oncology
Zip code
812-8582
Address
1-1-3 Maedashi, Fukuoka, Japan
TEL
092-642-5441
masaotan@surg1.med.kyushu-u.ac.jp
Public contact
Name of contact person
| 1st name | Kenoki |
| Middle name | |
| Last name | Ohuchida |
Organization
Kyushu university
Division name
Department of surgery and oncology
Zip code
812-8582
Address
1-1-3 Maedashi, Fukuoka, Japan
TEL
092-642-5441
Homepage URL
kenoki@surg1.med.kyushu-u.ac.jp
Sponsor or person
Institute
Department of surgery and oncology, Kyushu university
Institute
Department
Personal name
Funding Source
Organization
Kyushu university hospital
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
Kyushu University
Address
3-1-1 Maedashi Fukuoka
Tel
092-642-5444
kenoki@surg1.med.kyushu-u.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
Other administrative information
Date of disclosure of the study information
| 2014 | Year | 03 | 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
Completed
Date of protocol fixation
| 2013 | Year | 03 | Month | 01 | Day |
Date of IRB
| 2013 | Year | 03 | Month | 01 | Day |
Anticipated trial start date
| 2013 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2019 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2014 | Year | 02 | Month | 26 | Day |
Last modified on
| 2019 | Year | 09 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015486
| 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 |
