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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000016450
Receipt No. R000019109
Scientific Title Feasibility of a novel extra-wide-angle-view colonoscope: a clinical study
Date of disclosure of the study information 2015/02/05
Last modified on 2015/02/05

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Basic information
Public title Feasibility of a novel extra-wide-angle-view colonoscope: a clinical study
Acronym Feasibility of a novel extra-wide-angle-view colonoscope
Scientific Title Feasibility of a novel extra-wide-angle-view colonoscope: a clinical study
Scientific Title:Acronym Feasibility of a novel extra-wide-angle-view colonoscope
Region
Japan

Condition
Condition colorectal lesions
Classification by specialty
Gastroenterology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To evaluate the usefulness of a novel colonoscope.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Safety of a novel colonoscope
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Diagnosis
Type of intervention
Device,equipment
Interventions/Control_1 colonoscopy
Interventions/Control_2
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 no symptom (screening, FIT(+), PET(+)),
symptom (abd. pain, melena/anal bleeding)
Key exclusion criteria acute colitis, inflammatory bowel syndrome, post colorectomy.
Target sample size 50

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Shinji Tanaka
Organization Hiroshima University Hospital
Division name Department of Endoscopy
Zip code
Address 1-2-3, Kasumi, MInami-ku, Hiroshima
TEL 082-257-5538
Email colon@hiroshima-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Toshio Uraoka
Organization Okayama University Hospital
Division name Department of Endoscopy
Zip code
Address 2-5-2, Shikata-cho, Kita-ku, Okayama
TEL 086-235-7219
Homepage URL
Email toshi_urao@yahoo.co.jp

Sponsor
Institute Hiroshima University, Okayama University, National Cancer Center, Kyushu University
Institute
Department

Funding Source
Organization non
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 岡山大学病院、広島大学病院

Other administrative information
Date of disclosure of the study information
2015 Year 02 Month 05 Day

Related information
URL releasing protocol
Publication of results Partially published

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
2010 Year 02 Month 22 Day
Date of IRB
Anticipated trial start date
2010 Year 03 Month 15 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 02 Month 05 Day
Last modified on
2015 Year 02 Month 05 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019109

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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