UMIN-CTR Clinical Trial

Basic information
Public title	Evaluation of efficacy of hood assisted colonoscopy in trainees
Acronym	Evaluation of efficacy of hood assisted colonoscopy in trainees
Scientific Title	Evaluation of efficacy of hood assisted colonoscopy in trainees
Scientific Title:Acronym	Evaluation of efficacy of hood assisted colonoscopy in trainees
Region	Japan

Condition
Condition	whole field of colon disease
Classification by specialty	Gastroenterology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To clarify the efficacy of hood for total colonoscopy in trainees
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	The relationship between hood assited colonoscopy and cecal intubation rate
Key secondary outcomes	The relationship between hood assited colonoscopy and cecal intubation time The relationship between hood assited colonoscopy and patient discomfort

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -no one is blinded
Control	Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Prevention
Type of intervention	Device,equipment
Interventions/Control_1	attach hood
Interventions/Control_2	not attach 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	Patient who need colonoscopy
Key exclusion criteria	emergent colonoscopy colonic obstruction gastrointestinal bleeding
Target sample size	600

Research contact person
Name of lead principal investigator	1st name Koji Middle name Last name Takemoto
Organization	Tsuyama Chuo Hospital
Division name	Gastrointestinal Endoscopy Center
Zip code	708-0841
Address	1756 Kawasaki Tsuyama City Okayama Prefecture Japan
TEL	0868-21-8111
Email	soichiro.ako@gmail.com

Public contact
Name of contact person	1st name Soichiro Middle name Last name Ako
Organization	Tsuyama Chuo Hospital
Division name	Gastrointestinal Endoscopy Center
Zip code	708-0841
Address	1756 Kawasaki Tsuyama City Okayama Prefecture Japan
TEL	0868-21-8111
Homepage URL
Email	soichiro.ako@gmail.com

Sponsor
Institute	Tsuyama Chuo Hospital
Institute
Department

Funding Source
Organization	Tsuyama Chuo Hospital
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Tsuyama Chuo Hospital
Address	1756 Kawasaki Tsuyama City Okayama Prefecture Japan
Tel	0868-21-8111
Email	soichiro.ako@gmail.com

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	津山中央病院（岡山県）

Other administrative information
Date of disclosure of the study information	2013 Year 05 Month 07 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	Terminated
Date of protocol fixation	2013 Year 04 Month 03 Day
Date of IRB	2013 Year 04 Month 03 Day
Anticipated trial start date	2013 Year 05 Month 01 Day
Last follow-up date	2015 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2013 Year 05 Month 06 Day
Last modified on	2020 Year 05 Month 21 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000012409