UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000028841 |
|---|---|
| Receipt number | R000033009 |
| Scientific Title | Evaluation of complete cold forceps polypectomy resection rate for 3- to 5-mm colorectal polyps |
| Date of disclosure of the study information | 2017/11/01 |
| Last modified on | 2020/09/09 14:25:51 |
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Basic information
Public title
Evaluation of complete cold forceps polypectomy resection rate for 3- to 5-mm colorectal polyps
Acronym
C-CFP study
Scientific Title
Evaluation of complete cold forceps polypectomy resection rate for 3- to 5-mm colorectal polyps
Scientific Title:Acronym
C-CFP study
Region
| Japan |
Condition
Condition
colorectal polyp
Classification by specialty
| Gastroenterology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the efficacy of cold forceps polypectomy (CFP) using jumbo biopsy forceps for diminutive colorectal polyps
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Phase II
Assessment
Primary outcomes
Complete resection rate
Key secondary outcomes
Times of CFP
Complete resection rate according to the polyp size
Procedure time
Adverse events
Histology
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
Cold Forceps Polypectomy (CFP) using JUMBO biopsy forceps
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Colorectal polyp 3-5mm in size (adenoma or SSA/P)
Key exclusion criteria
Suspicious of cancer
Patient with familial adenomatous polyposis
Patient with inflammatory bowel disease
Patient with pregnancy
Patient who have been judged as in appropriate for this study
Target sample size
120
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hiroyuki Okada |
Organization
Okayama University Hospital
Division name
Gastroenterology
Zip code
Address
2-5-1 Shikata-cho, Kita-ku, Okayama-city, Okayama 700-8558, Japan
TEL
+81-86-235-7219
hiro@md.okayama-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yasushi Yamasaki |
Organization
Okayama University Hospital
Division name
Gastroenterology
Zip code
Address
2-5-1 Shikata-cho, Kita-ku, Okayama-city, Okayama 700-8558, Japan
TEL
+81-86-235-7219
Homepage URL
yasshifive@yahoo.co.jp
Sponsor or person
Institute
Okayama University Hospital
Department of Gastroenterology
Institute
Department
Personal name
Funding Source
Organization
Okayama University 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
Address
Tel
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
| 2017 | Year | 11 | 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
| 2017 | Year | 10 | Month | 31 | Day |
Date of IRB
| 2017 | Year | 10 | Month | 17 | Day |
Anticipated trial start date
| 2017 | Year | 10 | Month | 31 | Day |
Last follow-up date
| 2019 | Year | 06 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
| 2019 | Year | 12 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2017 | Year | 08 | Month | 25 | Day |
Last modified on
| 2020 | Year | 09 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033009
