UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	cecal intubation time and detection rate of colonic polyp due to endocuff-assisted colonoscopy compared with cap-assisted colonoscopy
Title of the study (Brief title)	cecal intubation time and detection rate of colonic polyp due to endocuff-assisted colonoscopy
Region	Japan

Condition
Condition	patients undergoing colonoscopy
Classification by specialty	Medicine in general Gastroenterology
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To analyze cecal intubation time and detection rate of colonic polyp due to endocuff or cap assisted colonoscopy
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	cecal intubation time and detection rate of colonic pol
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	attachment of endocuf
Interventions/Control_2	attachment of cap
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	patients undergoing colonoscopy
Key exclusion criteria	no cleansing, ileus,stricture,fistula,postcolectomy,active IBD,diverticulitis,colonic bleeding,severe heart dysfunction, severe liver dysfunction, severe renal dysfunction, pregnncy
Target sample size	500

Research contact person
Name of lead principal investigator	Hiroyuki Imaeda
Organization	Saitama Medical University Hospital
Division name	Department of General Internal Medicine
Address	38 Morohongo, Moroyama-machi, Iruma-gun, Saitama
TEL	049-276-1667
Email	imaedahi@saitama-med.ac.jp

Public contact
Name of contact person	Hiroyuki Imaeda
Organization	Saitama Medical University Hospital
Division name	Department of General Internal Medicine
Address	38 Morohongo, Moroyama-machi, Iruma-gun, Saitama
TEL	049-276-1667
Homepage URL
Email	imaedahi@saitama-med.ac.jp

Sponsor
Institute	Saitama Medical University Hospital
Institute
Department

Funding Source
Organization	Saitama Medical University Hospital
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	2015 Year 02 Month 10 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2015 Year 01 Month 19 Day
Anticipated trial start date	2015 Year 02 Month 10 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	2015 Year 01 Month 20 Day
Last modified on	2017 Year 02 Month 21 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000018888