UMIN-CTR Clinical Trial

Basic information
Public title	The detection rate of colorectal polyps with an artificial intelligence algorithm in the dynamic analysis using video clips
Acronym	The detection rate of colorectal polyps with an artificial intelligence algorithm in the dynamic analysis using video clips
Scientific Title	The detection rate of colorectal polyps with an artificial intelligence algorithm in the dynamic analysis using video clips
Scientific Title:Acronym	The detection rate of colorectal polyps with an artificial intelligence algorithm in the dynamic analysis using video clips
Region	Japan

Condition
Condition	Patients underwent endoscopic resection for colorectal lesions between June 2017 and February 2018 at the Jikei university hospital.
Classification by specialty	Gastroenterology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	The aim of this study was to evaluate the detectability for colorectal lesions with computer aided diagnosis (CAD) system using stored videos during endoscopic treatment for colorectal lesions.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Outcomes of study were diagnostic performances.
Key secondary outcomes	Outcome of study was the median time delay of lesion detection by CAD and the success rate of lesion localization .

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	Not applicable
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	Patients underwent endoscopic resection for colorectal lesions between June 2017 and February 2018 at the Jikei university hospital.
Key exclusion criteria	We excluded the cases from analysis that did not record intubation or withdrawal of a scope and stored for CAD system training.
Target sample size	20

Research contact person
Name of lead principal investigator	1st name Hiroaki Middle name Last name Matsui
Organization	The Jikei University School of Medicine
Division name	Department of Endoscopy
Zip code	105-8461
Address	3-25-8 Nishishimbashi, Minato-ku, Tokyo, Japan
TEL	03-3433-1111
Email	hiro24tht80@yahoo.co.jp

Public contact
Name of contact person	1st name Hiroaki Middle name Last name Matsui
Organization	The Jikei University School of Medicine
Division name	Department of Endoscopy
Zip code	105-8461
Address	3-25-8 Nishishimbashi, Minato-ku, Tokyo, Japan
TEL	03-3433-1111
Homepage URL
Email	hiro24tht80@yahoo.co.jp

Sponsor
Institute	Department of Endoscopy, The Jikei University School of Medicine
Institute
Department

Funding Source
Organization	Japan Agency for Medical Research and Development
Organization
Division
Category of Funding Organization	Japanese Governmental office
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization	the Ethics Committees of the Jikei University School of Medicine
Address	3-25-8 Nishishimbashi, Minato-ku, Tokyo, Japan
Tel	03-3433-1111
Email	rinri@jikei.ac.jp

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	2020 Year 03 Month 17 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	20
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	No longer recruiting
Date of protocol fixation	2018 Year 09 Month 13 Day
Date of IRB	2018 Year 09 Month 13 Day
Anticipated trial start date	2018 Year 09 Month 13 Day
Last follow-up date	2020 Year 03 Month 18 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	The study was approved again by the Ethics Committees of the Jikei University School of Medicine on 7 August 2019.

Management information
Registered date	2020 Year 03 Month 17 Day
Last modified on	2020 Year 03 Month 17 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045444