UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000013566 |
|---|---|
| Receipt number | R000015852 |
| Scientific Title | Safety and efficacy of colorectal endoscopic submucosal dissection(ESD) by the ESD beginners introduction after training by an animal model |
| Date of disclosure of the study information | 2014/03/31 |
| Last modified on | 2014/12/21 18:17:45 |
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Basic information
Public title
Safety and efficacy of colorectal endoscopic submucosal dissection(ESD) by the ESD beginners introduction after training by an animal model
Acronym
Safety and efficacy of colorectal endoscopic submucosal dissection(ESD) by the ESD beginners introduction after training by an animal model
Scientific Title
Safety and efficacy of colorectal endoscopic submucosal dissection(ESD) by the ESD beginners introduction after training by an animal model
Scientific Title:Acronym
Safety and efficacy of colorectal endoscopic submucosal dissection(ESD) by the ESD beginners introduction after training by an animal model
Region
| Japan |
Condition
Condition
colorectal neoplasm
Classification by specialty
| Gastroenterology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study is to assess the safety and efficacy of endoscopic submucosal dissection for colorectal by the ESD beginners introduction under expert's supervision after enough training by an animal model.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Completion rate
Key secondary outcomes
operation time,complication rate,number of mucosal injection,volume of mucosal injection,en bloc resection rate
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-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
| Maneuver |
Interventions/Control_1
treatment
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
Patients who have colorectal neoplasms larger than 20mm in diameter
Key exclusion criteria
1.Patients by whom consent was not got by informed consent
2.Patients who have reccurent lesions
Target sample size
80
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yohei Minato/Kouichi Nonaka |
Organization
NTT Medical Centor Tokyo
Division name
Department of Gastoroenterology
Zip code
Address
5-9-22,Higashi-Gotanda,Shinagawa-Ku,Tokyo
TEL
03-3448-6111
yoheiminato55925@gmail.com
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yohei Minato |
Organization
NTT Medical Centor Tokyo
Division name
Department of Gastoroenterology
Zip code
Address
5-9-22,Higashi-Gotanda,Shinagawa-Ku,Tokyo
TEL
03-3448-6111
Homepage URL
yoheiminato55925@gmail.com
Sponsor or person
Institute
NTT Medical Centor Tokyo
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
Other administrative information
Date of disclosure of the study information
| 2014 | Year | 03 | Month | 31 | 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
| 2014 | Year | 03 | Month | 31 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 04 | 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
| 2014 | Year | 03 | Month | 30 | Day |
Last modified on
| 2014 | Year | 12 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015852
