UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000008718 |
|---|---|
| Receipt number | R000010174 |
| Scientific Title | A novel colonoscope for colorectal polyp detection: a multicenter study |
| Date of disclosure of the study information | 2012/08/17 |
| Last modified on | 2016/09/05 22:21:07 |
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Basic information
Public title
A novel colonoscope for colorectal polyp detection: a multicenter study
Acronym
A novel colonoscope for colorectal polyp detection: a multicenter study
Scientific Title
A novel colonoscope for colorectal polyp detection: a multicenter study
Scientific Title:Acronym
A novel colonoscope for colorectal polyp detection: a multicenter study
Region
| Japan |
Condition
Condition
colorectal lesions
Classification by specialty
| Gastroenterology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To assess the efficacy of a novel colonoscope for the detection of colorectal lesions
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Phase III
Assessment
Primary outcomes
Detection rate of colorectal neoplastic lesions using a a novel colonoscope
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are blinded
Control
Active
Stratification
YES
Dynamic allocation
YES
Institution consideration
Institution is considered as adjustment factor in dynamic allocation.
Blocking
YES
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Diagnosis
Type of intervention
| Device,equipment | Maneuver |
Interventions/Control_1
A novel colonoscope group
Interventions/Control_2
Standard colonoscope group
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
| 80 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Colorectal cancer screening or polyp surveillance.
Key exclusion criteria
Patients with genetic syndromes such as hereditary non-polypoid colon cancer (HNPCC) and familial adenomatous polyposis; inflammatory bowel disease; active bleeding; or a previous colonic resection.
Target sample size
320
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Shinji Tanaka |
Organization
Hiroshima University Hospital
Division name
Department of Endoscopy
Zip code
Address
1-2-3 Kasumi, Minami-ku, Hiroshima, Japan
TEL
082-257-5538
colon@hiroshima-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Toshio Uraoka |
Organization
School of Medicine, Keio University
Division name
Division of Research and Development for Minimally Invasive Treatment, Cancer Center
Zip code
Address
35 Shinanomachi, Shinjuku-ku, Tokyo, Japan
TEL
03-5363-3437
Homepage URL
turaoka@a3.keio.jp
Sponsor or person
Institute
Kyushu University, Keio University, National Cancer Center Hospital, Hiroshima University
Institute
Department
Personal name
Funding Source
Organization
None
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
九州大学（福岡県）、慶應義塾大学（東京都）、国立がん研究センター中央病院（東京都）、広島大学（広島県）
Other administrative information
Date of disclosure of the study information
| 2012 | Year | 08 | Month | 17 | 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
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
| 2011 | Year | 04 | Month | 24 | Day |
Date of IRB
Anticipated trial start date
| 2011 | Year | 05 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
| 2012 | Year | 11 | Month | 11 | Day |
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2012 | Year | 08 | Month | 17 | Day |
Last modified on
| 2016 | Year | 09 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010174
