UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000057495 |
|---|---|
| Receipt number | R000065418 |
| Scientific Title | Polypectomy with snare clamping for pedunculated polyps: development of Stalk Clamping Polypectomy (SCP) |
| Date of disclosure of the study information | 2025/04/02 |
| Last modified on | 2025/04/02 21:37:03 |
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Basic information
Public title
Polypectomy with snare clamping for pedunculated polyps: development of Stalk Clamping Polypectomy (SCP)
Acronym
SCP trial
Scientific Title
Polypectomy with snare clamping for pedunculated polyps: development of Stalk Clamping Polypectomy (SCP)
Scientific Title:Acronym
SCP trial
Region
| Japan |
Condition
Condition
colonic pedunculated polyps
Classification by specialty
| Gastroenterology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To investigate the effect of bleeding prevention in patients who underwent Stalk Clamping Polypectomy for colonic pedunculated polyps.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Bleeding rate of SCP for pedunculated polyps
Key secondary outcomes
1. Comparative study of bleeding rates in CT(clamping time) 1 min and CT 2 min
2. Comparison of haemorrhage rates: site of occupancy, tumor size, with and without antithrombotic drugs, with or without additional hemostatic treatment after resection
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
| 20 | years-old | <= |
Age-upper limit
| 99 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
A case of endoscopic resection with SCP after diagnosis of colonic pedunculated polyps.
Key exclusion criteria
1. Endoscopic resection of pedunculated polyps of the colon without SCP.
2. Other patients deemed unsuitable for the study by the principal investigator or sub-investigator.
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Kensei |
| Middle name | |
| Last name | Ohtsu |
Organization
Tobata Kyoritsu Hospital
Division name
Department of Gastroenterology
Zip code
804-0093
Address
2-5-1 Sawami, Tobata-ku, Kitakyushu, Fukuoka, Japan
TEL
093-871-5421
k.ohtsu0120@gmail.com
Public contact
Name of contact person
| 1st name | Kensei |
| Middle name | |
| Last name | Ohtsu |
Organization
Tobata Kyoritsu Hospital
Division name
Department of Gastroenterology
Zip code
804-0093
Address
2-5-1 Sawami, Tobata-ku, Kitakyushu, Fukuoka, Japan
TEL
093-871-5421
Homepage URL
k.ohtsu0120@gmail.com
Sponsor or person
Institute
Tobata Kyoritsu Hospital
Institute
Department
Personal name
Kensei Ohtsu
Funding Source
Organization
Tobata Kyoritsu Hospital
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
Tobata Kyoritsu Hospital Ethics Review Committee
Address
2-5-1 Sawami Tobata-ku Kitakyushu Fukuoka Japan
Tel
093-871-5421
k.ohtsu0120@gmail.com
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
| 2025 | Year | 04 | Month | 02 | 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
50
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
No longer recruiting
Date of protocol fixation
| 2025 | Year | 02 | Month | 18 | Day |
Date of IRB
| 2025 | Year | 03 | Month | 31 | Day |
Anticipated trial start date
| 2025 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2025 | Year | 07 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Information is collected based on the electronic medical record.
Management information
Registered date
| 2025 | Year | 04 | Month | 02 | Day |
Last modified on
| 2025 | Year | 04 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000065418
