UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000048503 |
|---|---|
| Receipt number | R000055274 |
| Scientific Title | Feasibility study of modified underwater endoscopic mucosal resection (EMR) for colorectal polyps. |
| Date of disclosure of the study information | 2023/01/13 |
| Last modified on | 2023/01/05 16:32:39 |
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Basic information
Public title
Feasibility study of modified underwater endoscopic mucosal resection (EMR) for colorectal polyps.
Acronym
Feasibility study of modified underwater endoscopic mucosal resection (EMR) for colorectal polyps.
Scientific Title
Feasibility study of modified underwater endoscopic mucosal resection (EMR) for colorectal polyps.
Scientific Title:Acronym
Feasibility study of modified underwater endoscopic mucosal resection (EMR) for colorectal polyps.
Region
| Japan |
Condition
Condition
corolectal polyps
Classification by specialty
| Gastroenterology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Evaluation of the efficacy and safty modified underwater endoscopic mucosal resection (EMR)for corolectal polyps
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Pathological complete resection rate, Adverse event
Key secondary outcomes
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
Modified underwater EMR
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
| 80 | years-old | >= |
Gender
Male
Key inclusion criteria
Those for which consent has been obtained for this study.
Patients with colorectal polyps 10-25 mm in size.
Key exclusion criteria
Stemmed polyps
Cases with marked electrolyte imbalance
Dysfunction of important organs (heart, lungs, liver, kidneys, etc.)
Difficult to obtain written consent
The attending physician determines that it is inappropriate
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Tetsuji |
| Middle name | |
| Last name | Takayama |
Organization
Institute of Biomedical Sciences, Tokushima University Graduate School, Japan
Division name
Department of Gastroenterology and Oncology
Zip code
770-8503
Address
3-18-15, Kuramoto-cho, Tokushima city
TEL
+81-88-633-7124
takayama@tokushima-u.ac.jp
Public contact
Name of contact person
| 1st name | Kaizo |
| Middle name | |
| Last name | Kagemoto |
Organization
Institute of Biomedical Sciences, Tokushima University Graduate School, Japan
Division name
Department of Gastroenterology and Oncology
Zip code
770-8501
Address
3-18-15, Kuramoto-cho, Tokushima city
TEL
+819095586713
Homepage URL
ninai@tokushima-u.ac.jp
Sponsor or person
Institute
Institute of Biomedical Sciences, Tokushima University Graduate School, Japan
Institute
Department
Personal name
Funding Source
Organization
Institute of Biomedical Sciences, Tokushima University Graduate School, Japan
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
Tokushima University Hospital Life Science / Medical Research Ethics Review Board
Address
3-18-15, Kuramoto-cho, Tokushima city
Tel
+81-88-633-7124
ninai@tokushima-u.ac.jp
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
| 2023 | Year | 01 | Month | 13 | 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
Open public recruiting
Date of protocol fixation
| 2022 | Year | 07 | Month | 01 | Day |
Date of IRB
| 2022 | Year | 06 | Month | 28 | Day |
Anticipated trial start date
| 2022 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2025 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2022 | Year | 07 | Month | 28 | Day |
Last modified on
| 2023 | Year | 01 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000055274
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
