UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000015969
Receipt No. 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

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


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
Email 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
Email kuwait@kure-nh.go.jp

Sponsor
Institute Department of Gastroenterology, Kure Medical Cancer Center and Chugoku Cancer Center
Institute
Department

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
Email 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018574

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.