UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	colorectal polyp/adenoma detection rate due to Endocuff-assisted colonoscopy compared with standard colonoscopy
Title of the study (Brief title)	colorectal polyp/adenoma detection rate due to Endocuff-assisted colonoscopy
Region	Japan

Condition
Condition	colorectal polyp
Classification by specialty	Gastroenterology
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To evaluate colorectal polyp/adenoma detection rate due to Endocuff-assisted colonoscopy or standard colonoscopy
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	colorectal polyp/adenoma detection rate
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Cluster
Blinding	Single blind -participants are blinded
Control	Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Diagnosis
Type of intervention	Device,equipment
Interventions/Control_1	Endocuff-assisted colonoscopy
Interventions/Control_2	standard colonoscopy without a plastic hood
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	Not applicable
Gender	Male and Female
Key inclusion criteria	patients undergoing colonoscopy
Key exclusion criteria	previous bowel resection, inflammatory bowel disease and polyposis syndromes.
Target sample size	480

Research contact person
Name of lead principal investigator	Yoshiki Wada
Organization	Wada Clinic
Division name	Endoscopic department
Address	1-4-21, Oda, Wakayama
TEL	073-473-5252
Email	w-yoshi@mtj.biglobe.ne.jp

Public contact
Name of contact person	Yoshiki Wada
Organization	Wada Clinic
Division name	Endoscopic department
Address	1-4-21, Oda, Wakayama
TEL	073-473-5252
Homepage URL
Email	w-yoshi@mtj.biglobe.ne.jp

Sponsor
Institute	Wada Clinic
Institute
Department

Funding Source
Organization	Wada Clinic
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

Other administrative information
Date of disclosure of the study information	2017 Year 08 Month 20 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2015 Year 03 Month 20 Day
Anticipated trial start date	2015 Year 04 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2017 Year 08 Month 08 Day
Last modified on	2018 Year 04 Month 05 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032700