UMIN-CTR Clinical Trial

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
Last 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
Email	katsushi0324@hotmail.com

Public contact
1st 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
Email	katsushi0324@hotmail.com

Sponsor
Institute	Showa University, Northern Yokohama Hospital
Institute
Department

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
Email	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019818