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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000027969
Receipt No. 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

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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
Email 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
Email tojima@wakayama-med.ac.jp

Sponsor
Institute Wakayama Medical University, School of Medicine
Institute
Department

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
Email 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032039

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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