UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	A novel colonoscope for colorectal polyp detection: a multicenter study
Title of the study (Brief title)	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	Shinji Tanaka
Organization	Hiroshima University Hospital
Division name	Department of Endoscopy
Address	1-2-3 Kasumi, Minami-ku, Hiroshima, Japan
TEL	082-257-5538
Email	colon@hiroshima-u.ac.jp

Public contact
Name of contact person	Toshio Uraoka
Organization	School of Medicine, Keio University
Division name	Division of Research and Development for Minimally Invasive Treatment, Cancer Center
Address	35 Shinanomachi, Shinjuku-ku, Tokyo, Japan
TEL	03-5363-3437
Homepage URL
Email	turaoka@a3.keio.jp

Sponsor
Institute	Kyushu University, Keio University, National Cancer Center Hospital, Hiroshima University
Institute
Department

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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2011 Year 04 Month 24 Day
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

Related information
URL releasing protocol
Publication of results	Published
URL releasing results
Results
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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000010174