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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000007300
Receipt No. R000008602
Scientific Title The utility of new endoscopic system using the laser beam for the diagnosis of gastric cancer
Date of disclosure of the study information 2012/03/01
Last modified on 2013/02/19

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Basic information
Public title The utility of new endoscopic system using the laser beam for the diagnosis of gastric cancer
Acronym The utility of new endoscopic system using the laser beam for the diagnosis of gastric cancer
Scientific Title The utility of new endoscopic system using the laser beam for the diagnosis of gastric cancer
Scientific Title:Acronym The utility of new endoscopic system using the laser beam for the diagnosis of gastric cancer
Region
Japan

Condition
Condition early gastric cancer
Classification by specialty
Gastroenterology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To clarify the usefulness of new endoscopic system using the laser beam for the diagnosis of gastric cancer in magnified images
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Degree of diagnosis agreement according to VS classification of magnified endoscopic images with new endoscopic system and narrow band imaging
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 Diagnosis
Type of intervention
Device,equipment
Interventions/Control_1 endoscopic examination using new 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
100 years-old >=
Gender Male and Female
Key inclusion criteria Patients with early gastric cancer who receive endoscopic resection
Key exclusion criteria Patients whom a researcher judged to be inappropriate as a subject
Target sample size 100

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Mototsugu Kato
Organization Hokkaido University Hospital
Division name Division of Endoscopy
Zip code
Address Nishi-5, Kita-14, Kita-ku, Sapporo, Hokkaido 060-8638, Japan
TEL 011-716-1161
Email

Public contact
Name of contact person
1st name
Middle name
Last name
Organization Hokkaido University
Division name Division of Endoscopy
Zip code
Address
TEL 011-716-1161
Homepage URL
Email

Sponsor
Institute Division of Endoscopy, Hokkaido University Hospital
Institute
Department

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

Other administrative information
Date of disclosure of the study information
2012 Year 03 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
2012 Year 02 Month 01 Day
Date of IRB
Anticipated trial start date
2012 Year 03 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
2012 Year 02 Month 15 Day
Last modified on
2013 Year 02 Month 19 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008602

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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