UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000005048 |
|---|---|
| Receipt number | R000005895 |
| Scientific Title | Comparative study between schizor type endo-knife and insulated tipped knife 2 of ESD for EGC |
| Date of disclosure of the study information | 2011/02/08 |
| Last modified on | 2014/07/16 15:36:26 |
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Basic information
Public title
Comparative study between schizor type endo-knife and insulated tipped knife 2 of ESD for EGC
Acronym
Clutch cutter vs IT2 study
Scientific Title
Comparative study between schizor type endo-knife and insulated tipped knife 2 of ESD for EGC
Scientific Title:Acronym
Clutch cutter vs IT2 study
Region
| Japan |
Condition
Condition
early gastric cancer
Classification by specialty
| Gastroenterology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate efficasy of clutch cutter for gastric ESD compared with that of IT knife 2
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Self completion rate
Key secondary outcomes
Total treatment time
Complication rate
En bloc complete resection rate
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are blinded
Control
Active
Stratification
YES
Dynamic allocation
YES
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Pseudo-randomization
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
clutch cutter group
Interventions/Control_2
IT knife2 group
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
<2 cm differentiated type intramucosal carcinoma without ulceration
written confined informed consent
Key exclusion criteria
a lesion cardia or pylorus
patients with coagulopathy
patients with major organ failure
patients judged as inappropriate to enroll in this study by an operator
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Uedo Noriya |
Organization
Osaka medical center for cancer and cardiovascular diseases
Division name
Department of Gastrointestinal Oncology
Zip code
Address
1-3-3 Nakamichi,Higashinari-ku,Osaka
TEL
06-6972-1181
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Uedo Noriya |
Organization
Osaka medical center for cancer and cardiovascular diseases
Division name
Department of Gastrointestinal
Zip code
Address
1-3-3 Nakamichi,Higashinari-ku,Osaka
TEL
06-6972-1181
Homepage URL
Sponsor or person
Institute
Department of Gastrointestinal,Osaka medical center for cancer and cardiovascular diseases
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
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
大阪府立成人病センター（大阪府）
Other administrative information
Date of disclosure of the study information
| 2011 | Year | 02 | Month | 08 | 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
| 2010 | Year | 05 | Month | 24 | Day |
Date of IRB
Anticipated trial start date
| 2010 | Year | 11 | Month | 01 | Day |
Last follow-up date
| 2012 | Year | 03 | Month | 01 | Day |
Date of closure to data entry
| 2014 | Year | 07 | Month | 16 | Day |
Date trial data considered complete
| 2014 | Year | 07 | Month | 16 | Day |
Date analysis concluded
| 2014 | Year | 07 | Month | 16 | Day |
Other
Other related information
Management information
Registered date
| 2011 | Year | 02 | Month | 08 | Day |
Last modified on
| 2014 | Year | 07 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005895
