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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000005048
Receipt No. 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

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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
Email

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
Email

Sponsor
Institute Department of Gastrointestinal,Osaka medical center for cancer and cardiovascular diseases
Institute
Department

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
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 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005895

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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