UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000041718 |
|---|---|
| Receipt number | R000047619 |
| Scientific Title | Validation of the forced cold snare polypectomy (FCSP) |
| Date of disclosure of the study information | 2020/09/10 |
| Last modified on | 2024/03/11 21:01:36 |
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Basic information
Public title
Validation of the forced cold snare polypectomy (FCSP)
Acronym
Validation of the forced cold snare polypectomy (FCSP)
Scientific Title
Validation of the forced cold snare polypectomy (FCSP)
Scientific Title:Acronym
Validation of the forced cold snare polypectomy (FCSP)
Region
| Japan |
Condition
Condition
Colorectal polyps
Classification by specialty
| Gastroenterology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Validation of the forced cold snare polypectomy (FCSP)
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Frequency of the forced cold snare polypectomy
Key secondary outcomes
The complication rate of the forced cold snare polypectomy
The predictors for the forced cold snare polypectomy
The risk factors for protrusions within the cold snare defect (CSDPs)
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| 18 | years-old | <= |
Age-upper limit
| 100 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Patients with colorectal polyps were consequentially enrolled in the present study.
Key exclusion criteria
Patients whose lesions were found to be outside the guideline or expanded criteria for CSP by the endoscopic characteristics and histological findings of biopsy specimens.
Patients in disagreement with informed consent
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | Jun |
| Middle name | |
| Last name | Arimoto |
Organization
Omori Red Cross Hospital
Division name
Department of Gastroenterology
Zip code
143-8527
Address
4-30-1 Chuou Ohta-ku, Tokyo 143-8527, Japan
TEL
+81-3-3775-3111
junarimoto_junjun@yahoo.co.jp
Public contact
Name of contact person
| 1st name | Jun |
| Middle name | |
| Last name | Arimoto |
Organization
Omori Red Cross Hospital
Division name
Department of Gastroenterology
Zip code
143-8527
Address
4-30-1 Chuou Ohta-ku, Tokyo 143-8527, Japan
TEL
+81-3-3775-3111
Homepage URL
junarimoto_junjun@yahoo.co.jp
Sponsor or person
Institute
Omori Red Cross Hospital
Department of Gastroenterology
Institute
Department
Personal name
Funding Source
Organization
This study do not need financial support
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
Omori Red Cross Hospital
Address
4-30-1 Chuou Ohta-ku, Tokyo 143-8527, Japan
Tel
+81-3-3775-3111
junarimoto_junjun@yahoo.co.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
大森赤十字病院(東京都)
Other administrative information
Date of disclosure of the study information
| 2020 | Year | 09 | Month | 10 | Day |
Related information
URL releasing protocol
https://center6.umin.ac.jp/cgi-bin/icdr/ctr_up_reg_f5.cgi
Publication of results
Unpublished
Result
URL related to results and publications
https://center6.umin.ac.jp/cgi-open-bin/ctr/ctr_view.cgi?recptno=R000047619
Number of participants that the trial has enrolled
200
Results
Frequency of the forced cold snare polypectomy
Results date posted
| 2022 | Year | 03 | Month | 10 | Day |
Results Delayed
| Delay expected |
Results Delay Reason
Pandemic of COVID19
Date of the first journal publication of results
Baseline Characteristics
Patients with colorectal polyps were consequentially enrolled in the present study.
Participant flow
Patients with colorectal polyps were consequentially enrolled in the present study.
Adverse events
Bleeding
Perforation
Outcome measures
Frequency of the forced cold snare polypectomy
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2020 | Year | 09 | Month | 07 | Day |
Date of IRB
| 2020 | Year | 08 | Month | 24 | Day |
Anticipated trial start date
| 2020 | Year | 09 | Month | 11 | Day |
Last follow-up date
| 2020 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
| 2020 | Year | 12 | Month | 31 | Day |
Date trial data considered complete
| 2020 | Year | 12 | Month | 31 | Day |
Date analysis concluded
| 2021 | Year | 01 | Month | 31 | Day |
Other
Other related information
Observational study about validation of forced cold snare polypectomy.
The target lesion is adaptive lesion for colorectal CSP.
Management information
Registered date
| 2020 | Year | 09 | Month | 07 | Day |
Last modified on
| 2024 | Year | 03 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047619
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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