UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000000477 |
|---|---|
| Receipt number | 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 21:50:23 |
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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
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
kumai@sc.itc.keio.ac.jp
Sponsor or person
Institute
Keio University Hospital
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000573
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| Registered date | File name |
| Research case data | |
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