UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Evaluation of the novel computer-aided diagnosis system for colorectal lesions using endocytoscopy
Title of the study (Brief title)	Evaluation of the novel computer-aided diagnosis system for colorectal lesions using endocytoscopy
Region	Japan

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

Objectives
Narrative objectives1	The aim of the present study is to develop and evaluate a computer-aided diagnosis system for EC imaging of colorectal lesions.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Diagnostic ability (sensitivity, specificity, accuracy, positive predictive value, and negative predictive value) for colorectal polyp pathology
Key secondary outcomes	Comparison between the computer-aided diagnosis system and endoscopists(experts/trainees)

Base
Study type	Others,meta-analysis etc

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	18 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	Colon polyps which were resected after observation with endocytoscopy
Key exclusion criteria	Lesions whose images were unclear
Target sample size	100

Research contact person
Name of lead principal investigator	Yuichi Mori
Organization	Showa University Northern Yokohama Hospital
Division name	Digestive Disease Center
Address	35-1, Chigasakityuo, Tsuzuki-ku, Yokohama, Japan
TEL	045-949-7535
Email	ibusiginjp@hotmail.com

Public contact
Name of contact person	Yuichi Mori
Organization	Showa University Northern Yokohama Hospital
Division name	Digestive Disease Center
Address	35-1, Tsuzuki-ku, Chigasakityuo, Yokohama, Japan
TEL	045-949-7535
Homepage URL
Email	ibusiginjp@hotmail.com

Sponsor
Institute	Digestive Disease Center, Showa University Northern Yokohama Hospital
Institute
Department

Funding Source
Organization	Japan Society for the Promotion of Science
Organization
Division
Category of Funding Organization
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	昭和大学横浜市北部病院（神奈川県）

Other administrative information
Date of disclosure of the study information	2014 Year 01 Month 08 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2013 Year 11 Month 15 Day
Anticipated trial start date	2014 Year 01 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information	The Study will start on approval of IRB.

Management information
Registered date	2014 Year 01 Month 08 Day
Last modified on	2019 Year 01 Month 19 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014494