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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000000477
Receipt No. R000000573
Scientific Title Clinical evaluation of 2 channel scope XGIF-2TQ260R in the endoscopic submucosal resection for early gastric cancer
Date of disclosure of the study information 2006/08/24
Last modified on 2008/08/25

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Basic information
Public title Clinical evaluation of 2 channel scope XGIF-2TQ260R in the endoscopic submucosal resection for early gastric cancer
Acronym Clinical evaluation of XGIF-2TQ260R
Scientific Title Clinical evaluation of 2 channel scope XGIF-2TQ260R in the endoscopic submucosal resection for early gastric cancer
Scientific Title:Acronym Clinical evaluation of XGIF-2TQ260R
Region
Japan

Condition
Condition Early gastric cancer
Classification by specialty
Gastroenterology Gastrointestinal surgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 We will evaluate the clinical utility of 2 channel scope XGIF-2TQ260R which was improved in the swing function and flush channel addition in the treatment of early gastric cancer with endoscopic submucosal resection (ESD) technique.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Phase II

Assessment
Primary outcomes Operability
Key secondary outcomes Lump resection rate, procedure time, and accidental event occurrence frequency

Base
Study type Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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

Not applicable
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Early gastric cancer patient
Indication for EMR in JGCA gastric cancer treatment guidelines
Informed consent
Key exclusion criteria none
Target sample size 20

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Koichiro Kumai
Organization Keio University Hospital
Division name Center for Diagnostic and Therapeutic Endoscopy
Zip code
Address 35 Shinanomachi, Shinjuku-ku, Tokyo 160-8582, Japan
TEL 03-3353-1211
Email

Public contact
Name of contact person
1st name
Middle name
Last name Koichiro Kumai
Organization Keio University Hospital
Division name Center for Diagnostic and Therapeutic Endoscopy
Zip code
Address 35 Shinanomachi, Shinjuku-ku, Tokyo 160-8582, Japan
TEL 03-3353-1211
Homepage URL http://www.cimr.med.keio.ac.jp/ichiran.htm
Email kumai@sc.itc.keio.ac.jp

Sponsor
Institute Keio University Hospital
Institute
Department

Funding Source
Organization Olympus Medical Systems Corp.
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization Japan

Other related organizations
Co-sponsor none
Name of secondary funder(s) none

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
2006 Year 08 Month 24 Day

Related information
URL releasing protocol
Publication of results Partially 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
2006 Year 08 Month 14 Day
Date of IRB
Anticipated trial start date
2006 Year 08 Month 01 Day
Last follow-up date
2007 Year 04 Month 01 Day
Date of closure to data entry
2008 Year 08 Month 01 Day
Date trial data considered complete
2008 Year 08 Month 01 Day
Date analysis concluded
2008 Year 08 Month 01 Day

Other
Other related information Recruiting

Management information
Registered date
2006 Year 08 Month 23 Day
Last modified on
2008 Year 08 Month 25 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000573

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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