UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000017083 |
|---|---|
| Receipt number | R000019818 |
| Scientific Title | Narrow-band imaging versus white light for detection of diminutive colorectal adenoma using wide-view and high-definition colonoscope (HQ290ZI): A randomized controlled trial |
| Date of disclosure of the study information | 2015/04/09 |
| Last modified on | 2019/04/02 20:07:27 |
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Basic information
Public title
Narrow-band imaging versus white light for detection of diminutive colorectal adenoma using wide-view and high-definition colonoscope (HQ290ZI): A randomized controlled trial
Acronym
Narrow-band imaging versus white light for detection of diminutive colorectal adenoma using wide-view and high-definition colonoscope (HQ290ZI): a randomized controlled trial
Scientific Title
Narrow-band imaging versus white light for detection of diminutive colorectal adenoma using wide-view and high-definition colonoscope (HQ290ZI): A randomized controlled trial
Scientific Title:Acronym
Narrow-band imaging versus white light for detection of diminutive colorectal adenoma using wide-view and high-definition colonoscope (HQ290ZI): a randomized controlled trial
Region
| Japan |
Condition
Condition
colorectal adenoma
Classification by specialty
| Gastroenterology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate ability of narrow-band imaging for detetion of diminutive colorectal adenoma using wide-view and high definition colonosope (HQ290ZI)
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Comparison of narrow-band imaging versus white light imaging for diminutive adenoma detection rate
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Numbered container method
Intervention
No. of arms
2
Purpose of intervention
Diagnosis
Type of intervention
| Device,equipment |
Interventions/Control_1
narrow-band imagaing
Interventions/Control_2
white light
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
First colonoscopy patient
patient who has been tereated all colorectal polyps in the past colonoscopy
Key exclusion criteria
history of surgical resection for colorectum
inflammatory bowel deisease
Lynch syndrome
hereditary colorectal polyposis
active intestinal bleeding
colorectal stenosis
colorecatl diverticulosis
toxicic mega-colon
unsuccess of cecal insertion
poor colon creansing
antithrombotic drug
melanosis of colorectum
Target sample size
450
Research contact person
Name of lead principal investigator
| 1st name | Atsushi |
| Middle name | |
| Last name | Katagiri |
Organization
Showa University, Northern Yokohama Hospital
Division name
Digestive Disease Center
Zip code
224-8503
Address
35-1 Chigasaki-Chuo, Tsuzuki, Yokohama 224-8503, Japan
TEL
045-949-7000
katsushi0324@hotmail.com
Public contact
Name of contact person
| 1st name | Atsushi |
| Middle name | |
| Last name | Katagiri |
Organization
Showa University, Northern Yokohama Hospital
Division name
Digestive Disease Center
Zip code
224-8503
Address
35-1 Chigasaki-Chuo, Tsuzuki, Yokohama 224-8503, Japan
TEL
+81-45-949-7000
Homepage URL
katsushi0324@hotmail.com
Sponsor or person
Institute
Showa University, Northern Yokohama Hospital
Institute
Department
Personal name
Funding Source
Organization
Digestive Disease Center, Showa University, Northern Yokohama 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
Digestive Disease Center, Showa University, Northern Yokohama Hospital
Address
35-1 Chigasaki-Chuo, Tsuzuki, Yokohama 224-8503, Japan
Tel
045-949-7000
irb02syh@ofc.showa-u.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
昭和大学横浜市北部病院（神奈川県）
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 04 | Month | 09 | 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
No longer recruiting
Date of protocol fixation
| 2015 | Year | 03 | Month | 30 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 04 | Month | 13 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2015 | Year | 04 | Month | 09 | Day |
Last modified on
| 2019 | Year | 04 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019818
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
