UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000015969 |
|---|---|
| Receipt number | R000018574 |
| Scientific Title | Safety and Efficacy of Cold Biopsy Forceps Polypectomy for Diminutive Colorectal Polyps |
| Date of disclosure of the study information | 2015/01/29 |
| Last modified on | 2019/09/30 19:04:11 |
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Basic information
Public title
Safety and Efficacy of Cold Biopsy Forceps Polypectomy for Diminutive Colorectal Polyps
Acronym
Cold Biopsy for Diminutive Colorectal Polyps
Scientific Title
Safety and Efficacy of Cold Biopsy Forceps Polypectomy for Diminutive Colorectal Polyps
Scientific Title:Acronym
Cold Biopsy for Diminutive Colorectal Polyps
Region
| Japan |
Condition
Condition
Diminutive Colorectal Polyps
Classification by specialty
| Gastroenterology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the safety and efficacy of cold biopsy forceps polypectomy for diminutive colorectal polyps.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
recurrence rate
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
| 20 | years-old | <= |
Age-upper limit
| 75 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Patients with non-pedunculated colon polyps less than 5 mm.
Key exclusion criteria
Patients with inflammatory bowel disease and/or polyposis.
Patients with malignant neoplasms.
Target sample size
1000
Research contact person
Name of lead principal investigator
| 1st name | Toshio |
| Middle name | |
| Last name | Kuwai |
Organization
National Hospital Organization, Kure Medical Cancer Center and Chugoku Cancer Center
Division name
Department of Gastroenterology,
Zip code
7370023
Address
3-1 Aoyama-cho Kure, Hiroshima
TEL
0823-22-3111
kuwait@kure-nh.go.jp
Public contact
Name of contact person
| 1st name | Naoko |
| Middle name | |
| Last name | Matsumoto |
Organization
Kure Medical Cancer Center and Chugoku Cancer Center
Division name
Department of Gastroenterology
Zip code
7370023
Address
3-1 Aoyama-cho Kure, Hiroshima
TEL
0823-22-3111
Homepage URL
kuwait@kure-nh.go.jp
Sponsor or person
Institute
Department of Gastroenterology, Kure Medical Cancer Center and Chugoku Cancer Center
Institute
Department
Personal name
Funding Source
Organization
National Hospital Organization
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
NHO
Address
2-5-21, Higashigaoka, Meguro-ku, Tokyo
Tel
0357125050
kenkyu2004@hosp.go.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
| 2015 | Year | 01 | Month | 29 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
Number of participants that the trial has enrolled
503
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
| 2015 | Year | 01 | Month | 01 | Day |
Date of IRB
| 2014 | Year | 12 | Month | 20 | Day |
Anticipated trial start date
| 2015 | Year | 01 | Month | 01 | Day |
Last follow-up date
| 2019 | Year | 07 | Month | 12 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Multi-Institutional Cohort Study
Management information
Registered date
| 2014 | Year | 12 | Month | 16 | Day |
Last modified on
| 2019 | Year | 09 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018574
