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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000034987
Receipt No. R000039900
Official scientific title of the study Computer-aided detection for colonoscopy based on artificial intelligence
Date of disclosure of the study information 2018/12/01
Last modified on 2018/11/24

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Basic information
Official scientific title of the study Computer-aided detection for colonoscopy based on artificial intelligence
Title of the study (Brief title) Evaluation for CADe software
Region
Japan

Condition
Condition Colorectal lesions
Classification by specialty
Gastroenterology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To evaluate the efficacy of CADe software(EB-00) using colonoscopy video database.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes The sensitivity of CADe(EB-00) for colorectal lesions.
Key secondary outcomes

Base
Study type Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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 1)Pts who were performed colonoscopy in Showa University Northern Yokohama Hospital.
2)Over 20 years old.
3)Pts with informed consent.
Key exclusion criteria 1) Inflammatory bowel disease
2) Polyposis
Target sample size 70

Research contact person
Name of lead principal investigator Masashi Misawa
Organization Showa University Northern Yokohama Hospital
Division name Digestive Disease Center
Address Chigasaki-chuo 35-1, Tsuduki-ku, Yokohama
TEL 045-949-7265
Email mmisawa@med.showa-u.ac.jp

Public contact
Name of contact person Masashi Misawa
Organization Showa University Northern Yokohama Hospital
Division name Digestive Disease Center
Address Chigasaki-chuo 35-1, Tsuduki-ku, Yokohama
TEL 045-949-7265
Homepage URL
Email mmisawa@med.showa-u.ac.jp

Sponsor
Institute Showa University Northern Yokohama Hospital
Institute
Department

Funding Source
Organization None
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

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
2018 Year 12 Month 01 Day

Progress
Recruitment status No longer recruiting
Date of protocol fixation
2018 Year 07 Month 01 Day
Anticipated trial start date
2018 Year 08 Month 01 Day
Last follow-up date
Date of closure to data entry
2018 Year 10 Month 01 Day
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results Unpublished
URL releasing results
Results
Other related information We evaluated the performance of CADe software using colonoscopy video database which were taken at Showa University Northern Yokohama Hospital from August 2018 to October 2018.

Management information
Registered date
2018 Year 11 Month 24 Day
Last modified on
2018 Year 11 Month 24 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039900

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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