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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000009763
Receipt No. R000011404
Scientific Title Usefulness of a novel auto-fluorescence imaging system with computer-assisted color analysis for colorectal lesions
Date of disclosure of the study information 2013/01/15
Last modified on 2013/05/08

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Basic information
Public title Usefulness of a novel auto-fluorescence imaging system with computer-assisted color analysis for colorectal lesions
Acronym Colon a novelAFI Study
Scientific Title Usefulness of a novel auto-fluorescence imaging system with computer-assisted color analysis for colorectal lesions
Scientific Title:Acronym Colon a novelAFI Study
Region
Japan

Condition
Condition Neoplastic and non-neoplastic lesions of the colon
Classification by specialty
Gastroenterology Gastrointestinal surgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 The purpose of this study was to prospectively evaluate the efficacy of computer-assisted color analysis of colorectal lesions using the novel AFI system in distinguishing non-neoplastic lesions from neoplastic lesions.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Ability of differrential diagnosis(neoplastic,non-neoplastic)by using a novel AFI system.
Key secondary outcomes Diagnosing the depth of invasion of colorectal neoplasia by using a novel AFI system.

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 A novel AFI system
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
90 years-old >
Gender Male and Female
Key inclusion criteria The patients over 20 under 90 years old who undergo total colonoscopy.
Key exclusion criteria IBD
FAP
Target sample size 100

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Hiroko Inomata
Organization The Jikei University Hospital
Division name Depertment of Endoscopy
Zip code
Address 3-19-18 nishi-shinbashi Minatoku Tokyo Japan
TEL
Email

Public contact
Name of contact person
1st name
Middle name
Last name
Organization The Jikei University Hospital
Division name Depertment of Endoscopy
Zip code
Address
TEL
Homepage URL
Email hirokomoko@hotmail.co.jp

Sponsor
Institute Depertment of Endoscopy at The Jikei University Hospital
Institute
Department

Funding Source
Organization Depertment of Endoscopy at The Jikei University 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
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
2013 Year 01 Month 15 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 Open public recruiting
Date of protocol fixation
2012 Year 12 Month 28 Day
Date of IRB
Anticipated trial start date
2013 Year 02 Month 01 Day
Last follow-up date
2013 Year 04 Month 12 Day
Date of closure to data entry
2013 Year 04 Month 12 Day
Date trial data considered complete
2013 Year 04 Month 12 Day
Date analysis concluded
2013 Year 04 Month 30 Day

Other
Other related information

Management information
Registered date
2013 Year 01 Month 12 Day
Last modified on
2013 Year 05 Month 08 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011404

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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