UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000034987 |
|---|---|
| Receipt number | R000039900 |
| Scientific Title | Computer-aided detection for colonoscopy based on artificial intelligence |
| Date of disclosure of the study information | 2018/12/01 |
| Last modified on | 2022/11/29 08:53:54 |
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Basic information
Public title
Computer-aided detection for colonoscopy based on artificial intelligence
Acronym
Evaluation for CADe software
Scientific Title
Computer-aided detection for colonoscopy based on artificial intelligence
Scientific Title:Acronym
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
| 1st name | |
| Middle name | |
| Last name | Masashi Misawa |
Organization
Showa University Northern Yokohama Hospital
Division name
Digestive Disease Center
Zip code
Address
Chigasaki-chuo 35-1, Tsuduki-ku, Yokohama
TEL
045-949-7265
mmisawa@med.showa-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Masashi Misawa |
Organization
Showa University Northern Yokohama Hospital
Division name
Digestive Disease Center
Zip code
Address
Chigasaki-chuo 35-1, Tsuduki-ku, Yokohama
TEL
045-949-7265
Homepage URL
mmisawa@med.showa-u.ac.jp
Sponsor or person
Institute
Showa University Northern Yokohama Hospital
Institute
Department
Personal name
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)
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
| 2018 | Year | 12 | Month | 01 | 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
| 2018 | Year | 07 | Month | 01 | Day |
Date of IRB
| 2018 | Year | 07 | Month | 01 | Day |
Anticipated trial start date
| 2018 | Year | 08 | Month | 01 | Day |
Last follow-up date
| 2018 | Year | 09 | Month | 01 | Day |
Date of closure to data entry
| 2018 | Year | 10 | Month | 01 | Day |
Date trial data considered complete
Date analysis concluded
Other
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
| 2022 | Year | 11 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039900
