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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000003169
Receipt No. R000003844
Scientific Title Randomized controlled trail of new Harmonic FocusTM for gastric cancer surgery
Date of disclosure of the study information 2010/02/11
Last modified on 2013/03/02

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Basic information
Public title Randomized controlled trail of new Harmonic FocusTM for gastric cancer surgery
Acronym Randomized controlled trail of new Harmonic FocusTM for gastric cancer surgery
Scientific Title Randomized controlled trail of new Harmonic FocusTM for gastric cancer surgery
Scientific Title:Acronym Randomized controlled trail of new Harmonic FocusTM for gastric cancer surgery
Region
Japan

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

Objectives
Narrative objectives1 To study the efficacy and safety of Harmonic FocusTM for gastric cancer surgery and its impact on surgical education
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2
Developmental phase Phase II

Assessment
Primary outcomes Volume of blood loss
Key secondary outcomes Operation time, morbidity, cost, surgical education

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control Active
Stratification YES
Dynamic allocation YES
Institution consideration Institution is considered as a block.
Blocking YES
Concealment Central registration

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Device,equipment
Interventions/Control_1 Surgery with electro scalpel
Interventions/Control_2 Surgery with Harmonic Focus
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 Gastric cancer with histological examination
Potentially resectable with curative intent
ASA-PS: 1-3
Key exclusion criteria Emergency surgery
Target sample size 60

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Kentaro Inoue
Organization Kansai Medical University
Division name Surgery
Zip code
Address 2-3-1 shinmachi Hirakata-city, Japan
TEL 072-804-0101
Email

Public contact
Name of contact person
1st name
Middle name
Last name Kentaro Inoue
Organization Kansai Medical University
Division name Surgery
Zip code
Address 2-3-1 shinmachi Hirakata-city, Japan
TEL 072-804-0101
Homepage URL
Email inoueke@hirakata.kmu.ac.jp

Sponsor
Institute Department of Surgery
Kansai Medical University
Institute
Department

Funding Source
Organization Department of Surgery
Kansai Medical University
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 関西医科大学附属枚方病院

Other administrative information
Date of disclosure of the study information
2010 Year 02 Month 11 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
2010 Year 01 Month 28 Day
Date of IRB
Anticipated trial start date
2010 Year 02 Month 01 Day
Last follow-up date
2011 Year 02 Month 01 Day
Date of closure to data entry
2011 Year 08 Month 01 Day
Date trial data considered complete
2011 Year 08 Month 01 Day
Date analysis concluded
2011 Year 12 Month 01 Day

Other
Other related information

Management information
Registered date
2010 Year 02 Month 11 Day
Last modified on
2013 Year 03 Month 02 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003844

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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