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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000008115
Receipt No. R000009478
Scientific Title Examination of the colorectal endoscopic submucosal dissection (ESD) with traction device which made easy to resect the colorectal tumors.
Date of disclosure of the study information 2012/06/06
Last modified on 2012/06/06

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Basic information
Public title Examination of the colorectal endoscopic submucosal dissection (ESD) with traction device which made easy to resect the colorectal tumors.
Acronym Efficacy of the traction method for colorectal ESD
Scientific Title Examination of the colorectal endoscopic submucosal dissection (ESD) with traction device which made easy to resect the colorectal tumors.
Scientific Title:Acronym Efficacy of the traction method for colorectal ESD
Region
Japan

Condition
Condition More than 20mm superficial colorectal tumors which can be resected using endoscopy.
Classification by specialty
Gastroenterology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 In order to evaluate 1)preventing the complications 2)expended hours 3)success rate of en block resectionin and 4) recurrence rate of the ESD patients with superficial colorectal tumors.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Check for expended hours and success rate of en block resectionin of the ESD.
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Single arm
Randomization 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 Treatment
Type of intervention
Device,equipment
Interventions/Control_1 endoscopic clip
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

Not applicable
Gender Male and Female
Key inclusion criteria A patient who is diagnosed superficial colorectal tumor more than 20mm which can be resected using endoscopy.
"
Key exclusion criteria 1. A patient who can not be gained agreement with our informed consent.
2. A patient who is determined as ineligible for a subject in this study by a doctor in charge or others.
3. A recurrence lesion.
4. A lesion is suffered from non-lifting under the previous endoscopic treatment.
Target sample size 100

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Sakamoto
Organization Juntendo University
Division name Gastroenterology
Zip code
Address Hongo 3-1-3, Bunkyo-ku,Tokyo 113-8421,Japan
TEL
Email

Public contact
Name of contact person
1st name
Middle name
Last name
Organization Juntendo University
Division name Gastroenterology
Zip code
Address
TEL
Homepage URL
Email

Sponsor
Institute Juntendo University
Institute
Department

Funding Source
Organization Juntendo University
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 06 Month 06 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 07 Month 30 Day
Date of IRB
Anticipated trial start date
2010 Year 08 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 06 Month 06 Day
Last modified on
2012 Year 06 Month 06 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009478

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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