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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000024297
Receipt No. R000027982
Scientific Title Clinical study for feasibility and safety of robot-assisted gastrectomy using da Vinci surgical system
Date of disclosure of the study information 2017/01/01
Last modified on 2018/06/20

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Basic information
Public title Clinical study for feasibility and safety of robot-assisted gastrectomy using da Vinci surgical system
Acronym Feasibility and safety of robot-assisted gastrectomy
Scientific Title Clinical study for feasibility and safety of robot-assisted gastrectomy using da Vinci surgical system
Scientific Title:Acronym Feasibility and safety of robot-assisted gastrectomy
Region
Japan

Condition
Condition Gastric cancer
Classification by specialty
Gastrointestinal surgery Adult
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To meet the criteria for participating in multicenter clinical trial of robot-assisted gastrectomy
Basic objectives2 Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Intraoperative and postoperative morbidity
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
Maneuver
Interventions/Control_1 Robot-assisted gastrectomy
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
40 years-old <=
Age-upper limit
80 years-old >=
Gender Male and Female
Key inclusion criteria 1) Pathologically diagnosed with primary gastric cancer
2) Clinically diagnosed with stage I or II
3) Not indicated for EMR or ESD
4) 40 years old or more
5) Written informed concent
Key exclusion criteria 1) Preoperative therapy such as neoadjuvant chemotherapy
2) Patients with some difficulty in participating in the study such as mental disorder
Target sample size 7

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Toshiyoshi Fujiwara
Organization Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences
Division name Gastroenterological Surgery
Zip code
Address 2-5-1 Shikata-cho, Kita-ku, Okayama, Japan
TEL 086-235-7257
Email toshi_f@md.okayama-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Toshiyoshi Fujiwara
Organization Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences
Division name Gastroenterological Surgery
Zip code
Address 2-5-1 Shikata-cho, Kita-ku, Okayama, Japan
TEL 086-235-7257
Homepage URL
Email toshi_f@md.okayama-u.ac.jp

Sponsor
Institute Okayama University
Institute
Department

Funding Source
Organization N/A
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

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
2017 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 Completed
Date of protocol fixation
2016 Year 09 Month 27 Day
Date of IRB
Anticipated trial start date
2017 Year 01 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
2016 Year 10 Month 04 Day
Last modified on
2018 Year 06 Month 20 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027982

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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