UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000020180 |
|---|---|
| Receipt number | R000022280 |
| Scientific Title | Evaluation of the effectiveness of color intensity analysis using a second-generation autofluorescence imaging system for diminutive colorectal polyp differentiation. - prospective study - |
| Date of disclosure of the study information | 2015/12/14 |
| Last modified on | 2018/06/21 03:51:50 |
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Basic information
Public title
Evaluation of the effectiveness of color intensity analysis using a second-generation autofluorescence imaging system for diminutive colorectal polyp differentiation. - prospective study -
Acronym
Evaluation of the effectiveness of color intensity analysis using a second-generation autofluorescence imaging system for diminutive colorectal polyp differentiation. - prospective study -
Scientific Title
Evaluation of the effectiveness of color intensity analysis using a second-generation autofluorescence imaging system for diminutive colorectal polyp differentiation. - prospective study -
Scientific Title:Acronym
Evaluation of the effectiveness of color intensity analysis using a second-generation autofluorescence imaging system for diminutive colorectal polyp differentiation. - prospective study -
Region
| Japan |
Condition
Condition
Colorectal polyp
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluation the effectiveness of color tone intensity analysis using a second-generation AFI (autofluorescence imaging) system for evaluating diminutive colorectal lesions.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
The sensitivity, specificity, positive predictive value (PPV), and negative predictive value (NPV) of the AFI system for neoplastic lesion identification
Key secondary outcomes
The sensitivity, specificity, positive predictive value (PPV), and negative predictive value (NPV) of the normal white light imaging, Narrow band imaging system for neoplastic lesion identification
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
Auto Fluorescence Imaging will be permfomed when polyps(< 5mm) are detected for 5 - 10 seconds.
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients who is scheduled to be received endoscopic resection for colonic polyps.
Key exclusion criteria
1. Hemorrhagic tendency
2. In case of no consent of this trial.
3. Patients who have severe complications.
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hideka Horiuchi |
Organization
The Jikei university school of medicine
Division name
Department of endoscopy
Zip code
Address
3-25-8, Nishi-Shimbashi, Minato-ku,Tokyo,
TEL
+81-3-3433-1111
takeishihideka34@gmail.com
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hideka Horiuchi |
Organization
The Jikei university school of medicine
Division name
Department of endoscopy
Zip code
Address
3-25-8, Nishi-Shimbashi, Minato-ku,Tokyo,
TEL
+81-3-3433-1111
Homepage URL
takeishihideka34@gmail.com
Sponsor or person
Institute
The Jikei university school of medicine, department of endoscopy
Institute
Department
Personal name
Funding Source
Organization
The Jikei university school of medicine, department of endoscopy
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
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 | 12 | Month | 14 | 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 | 12 | Month | 14 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 12 | Month | 14 | 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 | 12 | Month | 14 | Day |
Last modified on
| 2018 | Year | 06 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022280
