UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000027969 |
|---|---|
| Receipt number | R000032039 |
| Scientific Title | Clinical trial on safety of robotic gastrectomy using a da Vinci surgical system for resectable gastric cancer |
| Date of disclosure of the study information | 2017/07/01 |
| Last modified on | 2019/07/01 07:50:18 |
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Basic information
Public title
Clinical trial on safety of robotic gastrectomy using a da Vinci surgical system for resectable gastric cancer
Acronym
Robotic gastrectomy for gastric cancer
Scientific Title
Clinical trial on safety of robotic gastrectomy using a da Vinci surgical system for resectable gastric cancer
Scientific Title:Acronym
Robotic gastrectomy for gastric cancer
Region
| Japan |
Condition
Condition
Resectable gastric cancer
Classification by specialty
| Gastrointestinal surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Assess the safety of robotic gastrectomy using da Vinci surgical system un clinical trial.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Phase I,II
Assessment
Primary outcomes
Postoperative complications more than Clavien-Dindo Grade II
Key secondary outcomes
Surgical outcomes
Postoperative courses
Disease free survival
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
Robotic gastrectomy using a da Vinci 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
(1) Histologically giagnosed gastric adenocarcinoma
(2) Patients with resectable gastric cancers
(3) For patient participation, written consent has been obtained from the patient
Key exclusion criteria
(1) Possible pregnancy
(2) Patients with mental disorders
(3) Patients having a history of myocardial infarction within 6 months or unstable angina
(4) Hypertension with poor control
(5) Combined respiratory diseases requiring sustained oxygen therapy
(6) Patients that the doctors judged in appropriate.
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | OJIMA |
| Middle name | |
| Last name | TOSHIYASU |
Organization
Wakayama Medical University, School of Medicine
Division name
Second Department of Surgery
Zip code
6418510
Address
811-1 Kimiidera, Wakayama city, Wakayama, Japan
TEL
073-441-0613
tojima@wakayama-med.ac.jp
Public contact
Name of contact person
| 1st name | Toshiyasu |
| Middle name | |
| Last name | Ojima |
Organization
Wakayama Medical University, School of Medicine
Division name
Second Department of Surgery
Zip code
6418510
Address
811-1 Kimiidera, Wakayama city, Wakayama, Japan
TEL
073-441-0613
Homepage URL
tojima@wakayama-med.ac.jp
Sponsor or person
Institute
Wakayama Medical University, School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Wakayama Medical University, School of Medicine
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
Wakayama Medical University
Address
Kimiidera 811-1 Wakayama
Tel
073-441-0613
tojima@wakayama-med.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
和歌山県立医科大学附属病院
Other administrative information
Date of disclosure of the study information
| 2017 | Year | 07 | 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
| 2017 | Year | 05 | Month | 10 | Day |
Date of IRB
| 2017 | Year | 04 | Month | 01 | Day |
Anticipated trial start date
| 2017 | Year | 05 | Month | 22 | Day |
Last follow-up date
| 2019 | Year | 05 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2017 | Year | 06 | Month | 28 | Day |
Last modified on
| 2019 | Year | 07 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032039
