UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000008115 |
|---|---|
| Receipt number | 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 20:47:15 |
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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
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
Juntendo University
Division name
Gastroenterology
Zip code
Address
TEL
Homepage URL
Sponsor or person
Institute
Juntendo University
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009478
