UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000039853 |
|---|---|
| Receipt number | R000045444 |
| Scientific Title | The detection rate of colorectal polyps with an artificial intelligence algorithm in the dynamic analysis using video clips |
| Date of disclosure of the study information | 2020/03/17 |
| Last modified on | 2020/03/17 18:37:17 |
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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
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
hiro24tht80@yahoo.co.jp
Sponsor or person
Institute
Department of Endoscopy, The Jikei University School of Medicine
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045444
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
