UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000005001
Receipt number R000005944
Scientific Title Study of feasibility and safety in Robot-assisted laparoscopic gastrectomy using da Vinci S Surgical System for gastric cancer.
Date of disclosure of the study information 2011/02/03
Last modified on 2018/01/04 09:53:48

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Basic information

Public title

Study of feasibility and safety in Robot-assisted laparoscopic gastrectomy using da Vinci S Surgical System for gastric cancer.

Acronym

feasibility and safety in Robot-assisted gastrectomy for gastric cancer.

Scientific Title

Study of feasibility and safety in Robot-assisted laparoscopic gastrectomy using da Vinci S Surgical System for gastric cancer.

Scientific Title:Acronym

feasibility and safety in Robot-assisted gastrectomy 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 evaluate the feasibility and safety of robot-assisted laparoscopic gastrectomy 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

frequency of adverse events

Key secondary outcomes

the accomplishment rate


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 Maneuver

Interventions/Control_1

The use of da Vinci S surgical System in laparoscopic gastrectomy for gastric cancer

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

18 years-old <=

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

1) Histologically proven gastric adenocarcinoma.
2) cStage IA(T1N0) .
3) No history of upper abdominal surgery and no history of intestinal resection.
4) Sufficient organ functions.
5) Written informed consent.

Key exclusion criteria

(1)Active synchronous cancers.
(2)Women during pregnancy or breast-feeding.
(3)Severe mental disease.
(4)Cases which is unsuitable for laparoscopic 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 Toshiyoshi Fujiwara

Organization

Okayama University

Division name

Okayama University Hospital, Department of Gastroenterological Surgery

Zip code


Address

2-5-1 Shikata-cho, Kita-ku, Okayama, 700-8558, Japan

TEL

+81-86-235-7257

Email

skagawa@md.okayama-u.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Shunsuke Kagawa

Organization

Okayama University

Division name

Okayama University Hospital, Department of Gastroenterological Surgery

Zip code


Address

2-5-1 Shikata-cho, Kita-ku, Okayama, 700-8558, Japan

TEL

+81-86-235-7257

Homepage URL


Email

skagawa@md.okayama-u.ac.jp


Sponsor or person

Institute

Okayama 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


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

岡山大学病院


Other administrative information

Date of disclosure of the study information

2011 Year 02 Month 03 Day


Related information

URL releasing protocol


Publication of results

Published


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

2011 Year 02 Month 01 Day

Date of IRB


Anticipated trial start date

2011 Year 02 Month 02 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

2011 Year 02 Month 02 Day

Last modified on

2018 Year 01 Month 04 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005944


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name