UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000054732 |
|---|---|
| Receipt number | R000062535 |
| Scientific Title | The resection ability of hot snare polypectomy with low power pure-cut current for nonpedunculated colorectal polyps less than 10 mm |
| Date of disclosure of the study information | 2024/06/24 |
| Last modified on | 2024/06/22 16:46:43 |
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Basic information
Public title
Prospective evaluation of hot snare polypectomy with low power pure-cut current for small polyps
Acronym
Low-power pure-cut hot snare polypectomy
Scientific Title
The resection ability of hot snare polypectomy with low power pure-cut current for nonpedunculated colorectal polyps less than 10 mm
Scientific Title:Acronym
Resection depth of LPPC-HSP
Region
| Japan |
Condition
Condition
Colorectal polyps
Classification by specialty
| Gastroenterology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the treatment outcomes of hot snare polypectomy with low-power pure-cut current,including resection ability for nonpedunculated colorectal polyps less than 10 mm
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The rate of R0 resection with submucosa
Key secondary outcomes
1.R0 resection rate
2.En bloc resection rate
3.Procedure time
4.Incidence of Adverse events
5.Incidence of the white protrusion at the ulcer bed
6.Presence of muscularis mucosa within the resected specimen
7.Presence of submucosal tissue within the resected specimen
8.Thickness of submucosal tissue within the resected specimen
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1. Patients with nonpedunculated colorectal polyps less than 10 mm
2. Patients aged 18 yrs or more
3. Patients with informed consent
Key exclusion criteria
1.Cases with inflammatory bowel disease
2.Cases with polyposis syndrome
3.Cases with blood coagulation dysfunction
4.Cases with active infection disease
5.Cases with dialysis
6.Cases who are pregnant or planning to become pregnant during the study period.
7.Cases who can not interrupt anticoagulant agents
8.When reserchers consider to be inappropriate cases
Target sample size
150
Research contact person
Name of lead principal investigator
| 1st name | Hidenori |
| Middle name | |
| Last name | Kimura |
Organization
Shiga University of Medical Science Hospital
Division name
Department of Endoscopy
Zip code
520-2192
Address
Seta tukinowatyo, Otsu city, Shiga, Japan
TEL
077-548-2217
kimura64@belle.shiga-med.ac.jp
Public contact
Name of contact person
| 1st name | Ryo |
| Middle name | |
| Last name | Mizuno |
Organization
Shiga University of Medical Science Hospital
Division name
Department of Gastroenterology
Zip code
520-2192
Address
Seta tukinowatyo, Otsu city, Shiga, Japan
TEL
077-548-2217
Homepage URL
mizuryo@belle.shiga-med.ac.jp
Sponsor or person
Institute
Shiga University of Medical Science Hospital
Institute
Department
Personal name
Funding Source
Organization
Self funding
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
Ethic committee of Shiga University of Medical Science Hospital
Address
Seta tukinowatyo, Otsu city, Shiga, Japan
Tel
077-548-3576
hqrec@belle.shiga-med.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
滋賀医科大学医学部附属病院（滋賀県）
Other administrative information
Date of disclosure of the study information
| 2024 | Year | 06 | Month | 24 | 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
Enrolling by invitation
Date of protocol fixation
| 2024 | Year | 05 | Month | 25 | Day |
Date of IRB
| 2024 | Year | 05 | Month | 28 | Day |
Anticipated trial start date
| 2024 | Year | 05 | Month | 28 | Day |
Last follow-up date
| 2027 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
The single center, single arm, prospective observational study
Management information
Registered date
| 2024 | Year | 06 | Month | 22 | Day |
Last modified on
| 2024 | Year | 06 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000062535
