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UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000007469
Receipt No. R000008733
Scientific Title A prospective randomized study on the effficacy of a colonoscope with passive bending function
Date of disclosure of the study information 2012/03/12
Last modified on 2012/03/08

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Basic information
Public title A prospective randomized study on the effficacy of a colonoscope with passive bending function
Acronym A prospective randomized study on a colonoscope with passive bending function
Scientific Title A prospective randomized study on the effficacy of a colonoscope with passive bending function
Scientific Title:Acronym A prospective randomized study on a colonoscope with passive bending function
Region
Japan

Condition
Condition Colorectal disease
Classification by specialty
Gastroenterology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To assess the efficacy of a colonoscope with passive bending function, comparing with a standard colonoscope: an analysis using magnetic endoscope imaging (MEI)
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Patient pain
Key secondary outcomes Cecal intubation rate
Cecal intubation time
Rate of looping
Complications

Base
Study type Interventional

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

Intervention
No. of arms 2
Purpose of intervention Prevention
Type of intervention
Device,equipment
Interventions/Control_1 Colonoscope with passive bendig function(PCF-Y0005L/I, Olympus, Tokyo, Japan)
and magnetic endoscopic imagining
Interventions/Control_2 Standard colonoscope(CF260AI, Olympus, Tokyo, Japan)
and magnetic endoscopic imagining
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 1, Age of more than 20 or less than 80 years old
2, Patients to recieve colonoscopy
3, Patients who have agreement to our
study
Key exclusion criteria 1,Those patients who are not able to
understand written information.
2, Patients with prior colectomy
3, Patients with immflammatory bowel
diseade
4, Patients with acute hemorrhagic
colitis
5, Pregnancy
6, Patients with pacemaker
Target sample size 300

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Koichiro Sato
Organization Toho University Ohashi Medical Center
Division name Division of Gastroenterology, Department of Internal Medicine
Zip code
Address 2-17-6 Ohashi, Meguro-ku, Tokyo 153-8515, Japan
TEL
Email

Public contact
Name of contact person
1st name
Middle name
Last name Koichiro Sato
Organization Toho University Ohashi Medical Center
Division name Division of Gastroenterology, Department of Internal Medicine
Zip code
Address 2-17-6 Ohashi, Meguro-ku, Tokyo 153-8515, Japan
TEL 03-3468-1251
Homepage URL
Email kou08@oha.toho-u.ac.jp

Sponsor
Institute Toho University Ohashi Medical Center
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)

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
2012 Year 03 Month 12 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 Open public recruiting
Date of protocol fixation
2011 Year 08 Month 20 Day
Date of IRB
Anticipated trial start date
2012 Year 03 Month 01 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
2012 Year 03 Month 08 Day
Last modified on
2012 Year 03 Month 08 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008733

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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