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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000016278
Receipt No. R000018888
Scientific Title cecal intubation time and detection rate of colonic polyp due to endocuff-assisted colonoscopy compared with cap-assisted colonoscopy
Date of disclosure of the study information 2015/02/10
Last modified on 2017/02/21

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Basic information
Public title cecal intubation time and detection rate of colonic polyp due to endocuff-assisted colonoscopy compared with cap-assisted colonoscopy
Acronym cecal intubation time and detection rate of colonic polyp due to endocuff-assisted colonoscopy
Scientific Title cecal intubation time and detection rate of colonic polyp due to endocuff-assisted colonoscopy compared with cap-assisted colonoscopy
Scientific Title:Acronym 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
1st name
Middle name
Last name Hiroyuki Imaeda
Organization Saitama Medical University Hospital
Division name Department of General Internal Medicine
Zip code
Address 38 Morohongo, Moroyama-machi, Iruma-gun, Saitama
TEL 049-276-1667
Email imaedahi@saitama-med.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Hiroyuki Imaeda
Organization Saitama Medical University Hospital
Division name Department of General Internal Medicine
Zip code
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)

IRB Contact (For public release)
Organization
Address
Tel
Email

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

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 Completed
Date of protocol fixation
2015 Year 01 Month 19 Day
Date of IRB
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

Other
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/ctr_e/ctr_view.cgi?recptno=R000018888

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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