UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000053414 |
|---|---|
| Receipt number | R000060960 |
| Scientific Title | Comparison of Cold Snare Polypectomy (CSP) and Hot Snare Polypectomy (HSP) in Lower GI Endoscopy |
| Date of disclosure of the study information | 2024/03/01 |
| Last modified on | 2024/01/23 17:42:37 |
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Basic information
Public title
A study to compare and evaluate the usefulness and safety of SSP (Seared Snare Polypectomy) and CSP (Cold Snare Polypectomy) in lower gastrointestinal endoscopy
Acronym
Investigation of the usefulness of SSP (Seared Snare Polypectomy)
Scientific Title
Comparison of Cold Snare Polypectomy (CSP) and Hot Snare Polypectomy (HSP) in Lower GI Endoscopy
Scientific Title:Acronym
Investigation of the usefulness of SSP (Seared Snare Polypectomy)
Region
| Japan |
Condition
Condition
colorectal polyp
Classification by specialty
| Gastroenterology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To clarify the safety and usefulness of Seared Snare Polypectomy (SSP) in lower gastrointestinal endoscopy.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Histological abscission negative rate of excised colorectal polyps in SSP and CSP
Key secondary outcomes
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
| 90 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Patients who have undergone or will undergo colorectal polypectomy at the time of lower gastrointestinal endoscopy will be included, and men and women between the ages of 18 and 90 years at the time of the examination.
Key exclusion criteria
Patients who refused to participate in the opt-out
Target sample size
500
Research contact person
Name of lead principal investigator
| 1st name | Shigeki |
| Middle name | |
| Last name | Tamura |
Organization
Yokohama City University School of Medicine
Division name
Department of Gastroenterology and Hepatology
Zip code
236-0004
Address
3-9 Fukuura, Kanazawa-ku, Yokohama, Kanagawa
TEL
0457872640
tamura.shi.gs@yokohama-cu.ac.jp
Public contact
Name of contact person
| 1st name | Shigeki |
| Middle name | |
| Last name | Tamura |
Organization
Yokohama City University School of Medicine
Division name
Department of Gastroenterology and Hepatology
Zip code
236-0004
Address
3-9 Fukuura, Kanazawa-ku, Yokohama, Kanagawa
TEL
0457872640
Homepage URL
tamura.shi.gs@yokohama-cu.ac.jp
Sponsor or person
Institute
Yokohama City University
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
Yokohama City University School of Medicine
Address
3-9 Fukuura, Kanazawa-ku, Yokohama, Kanagawa
Tel
0457872640
tamura.shi.gs@yokohama-cu.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
| 2024 | Year | 03 | 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
Preinitiation
Date of protocol fixation
| 2024 | Year | 01 | Month | 24 | Day |
Date of IRB
Anticipated trial start date
| 2017 | Year | 02 | Month | 07 | Day |
Last follow-up date
| 2026 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
none
Management information
Registered date
| 2024 | Year | 01 | Month | 23 | Day |
Last modified on
| 2024 | Year | 01 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000060960
| 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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| Registered date | File name |
