UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000055731 |
|---|---|
| Receipt number | R000063688 |
| Scientific Title | Effectiveness of Artificial Intelligence-Assisted Colorectal Lesion Detection System in Reducing Endoscopists' Viewpoint Shift |
| Date of disclosure of the study information | 2024/10/04 |
| Last modified on | 2024/10/03 17:53:21 |
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Basic information
Public title
Effectiveness of Artificial Intelligence-Assisted Colorectal Lesion Detection System in Reducing Endoscopists' Viewpoint Shift
Acronym
Effectiveness of Artificial Intelligence-Assisted Colorectal Lesion Detection System in Reducing Endoscopists' Viewpoint Shift
Scientific Title
Effectiveness of Artificial Intelligence-Assisted Colorectal Lesion Detection System in Reducing Endoscopists' Viewpoint Shift
Scientific Title:Acronym
Effectiveness of Artificial Intelligence-Assisted Colorectal Lesion Detection System in Reducing Endoscopists' Viewpoint Shift
Region
| Japan |
Condition
Condition
Colorectal adenoma
Classification by specialty
| Gastroenterology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to prospectively verify whether the use of CADe reduces the endoscopist's eye movement distance compared to the case without CADe and to establish a method to objectively evaluate it.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Difference in average distance of eye movement (Euclidean distance) per unit time (30 milliseconds)
Key secondary outcomes
1. The ratio of the number of eye movements over the threshold distance to the total number of eye movements (the threshold distance is subdivided into 300/600/900 pixels, each eye movement is measured in 30 milliseconds)
2. Average horizontal eye movement distance per unit time (30 ms)
3. Average of vertical eye movement distance per unit time (30 ms)
4. ADR between groups
5. APC across groups 6.
6. Adenoma miss rate (AMR) of the preceding modality between groups (AMR of CADe for CADe preceding group, AMR of usual observation for usual observation preceding group)
Serrated lesion identification rate between groups
8. Observation time between groups
9. Endoscopist eye fatigue as measured by visual analog scale (VAS) between groups
10. Eye movement patterns by endoscopist and ocular fatigue as measured by VAS
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are blinded
Control
Active
Stratification
YES
Dynamic allocation
YES
Institution consideration
Blocking
NO
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Device,equipment |
Interventions/Control_1
CADe-first group (observation with CADe followed by observation without CADe)
Interventions/Control_2
Normal observation-first group (observation without CADe followed by observation with CADe)
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
| 90 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1. Patients who are undergoing colonoscopy.
2. Patients between 20 and 90 years old.
3. Patients with performance status (ECOG) of 0 (no limitation in daily activities), 1 (able to perform light tasks but not physical labor), or 2 (able to walk and perform personal activities but not light tasks).
4. The patients' participation in the study has been fully explained, and their written consent has been obtained.
Key exclusion criteria
1. Patients with inflammatory bowel disease (ulcerative colitis, Crohn's disease, Behcet's disease).
2. Patients with hereditary or nonhereditary gastrointestinal polyposis.
3. Patients with hereditary non-polyposis colorectal cancer (Lynch syndrome).
4. Patients with known severe diverticular disease of the colon that makes colonoscopy difficult and dangerous.
5. Patients who are unable to take colonoscopy pretreatment medication (laxatives)
6. Patients who are allergic to colonoscopy preparation or sedatives.
7. Pregnant patients.
8. Patients who are breast-feeding.
9. Patients who do not consent to participate in the study
10. Patients who are deemed inappropriate by the study investigator.
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Fumiaki |
| Middle name | |
| Last name | Ishibashi |
Organization
International University of Health and Welfare Ichikawa Hospital
Division name
Department of Gastroenterology
Zip code
272-0827
Address
6-1-14, Konodai, Ichikawa-shi
TEL
0473751111
ishibashi-gast@iuhw.ac.jp
Public contact
Name of contact person
| 1st name | Fumiaki |
| Middle name | |
| Last name | Ishibashi |
Organization
International University of Health and Welfare Ichikawa Hospital
Division name
Department of Gastroenterology
Zip code
272-0827
Address
6-1-14, Konodai, Ichikawa-shi
TEL
0473751111
Homepage URL
ishibashi-gast@iuhw.ac.jp
Sponsor or person
Institute
International University of Health and Welfare Ichikawa Hospital
Institute
Department
Personal name
Funding Source
Organization
Japan Science and Technology Agency
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
Instituitional Review Board of International University of Health and Welfare
Address
852 Hatagada, Narita, Chiba
Tel
0476207708
rinri_md@iuhw.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
| 2024 | Year | 10 | Month | 04 | 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
60
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
| 2024 | Year | 04 | Month | 12 | Day |
Date of IRB
| 2024 | Year | 06 | Month | 06 | Day |
Anticipated trial start date
| 2024 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2024 | Year | 09 | Month | 30 | Day |
Date of closure to data entry
| 2024 | Year | 10 | Month | 31 | Day |
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2024 | Year | 10 | Month | 03 | Day |
Last modified on
| 2024 | Year | 10 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000063688
