UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000032874 |
|---|---|
| Receipt number | R000037483 |
| Scientific Title | cold snare EMR to colorectal polyp trial |
| Date of disclosure of the study information | 2018/08/01 |
| Last modified on | 2021/06/07 16:27:37 |
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Basic information
Public title
cold snare EMR to colorectal polyp trial
Acronym
cold snare EMR to colorectal polyp trial
Scientific Title
cold snare EMR to colorectal polyp trial
Scientific Title:Acronym
cold snare EMR to colorectal polyp trial
Region
| Japan |
Condition
Condition
colorectal polyp
Classification by specialty
| Gastroenterology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We aim to assess the histological accuracy and safety of cold snare EMR.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Rate of sample that can assess histological cut end.
Key secondary outcomes
post procudural bleeding, time of resection, and other complcation 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
NO
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
endoscopic resection
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
| 100 | years-old | > |
Gender
Male and Female
Key inclusion criteria
over 20 years old, PS 0-1. colorectal polyps smaller than 10mm. Hb over 9g/dl.AST/ALT cre normal. agree to the study.
Key exclusion criteria
cancer suspect polyp. pregnant. high fever
heart attack in three month.uncontrolled hypertension.study doctor judge unfit.continuous Oxygen administration
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | takashi |
| Middle name | |
| Last name | mamiya |
Organization
ryuugasaki saiseikai hospital
Division name
gastroenteorogy
Zip code
3010854
Address
igbaraki ryuugasaki nakasato 1-1
TEL
0297-63-7111
mamiya_tsukuba@yahoo.co.jp
Public contact
Name of contact person
| 1st name | takashi |
| Middle name | |
| Last name | mamiya |
Organization
ryuugasaki saiseikai hospital
Division name
gastroenteorogy
Zip code
301-0854
Address
igbaraki ryuugasaki nakasato 1-1
TEL
0297-63-7111
Homepage URL
mamiya_tsukuba@yahoo.co.jp
Sponsor or person
Institute
ryuugasaki saiseikai hospital
Institute
Department
Personal name
Funding Source
Organization
ryuugasaki saiseikai hospital
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
ryuugasakisaiseikai hospital
Address
ibaraki ryuugasaki nakasato 1-1
Tel
0297-63-7111
web_master@ryugasaki-hp.org
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
| 2018 | Year | 08 | Month | 01 | 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
| 2018 | Year | 06 | Month | 04 | Day |
Date of IRB
| 2018 | Year | 05 | Month | 30 | Day |
Anticipated trial start date
| 2018 | Year | 06 | Month | 04 | Day |
Last follow-up date
| 2022 | Year | 06 | Month | 04 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2018 | Year | 06 | Month | 05 | Day |
Last modified on
| 2021 | Year | 06 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037483
