UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000055006 |
|---|---|
| Receipt number | R000062840 |
| Scientific Title | EYE tracking technology based audio guidance of endoScopIst Gazing point for improvement of colorecTal adenoma detection A multi-center randomized trial |
| Date of disclosure of the study information | 2024/07/18 |
| Last modified on | 2024/10/03 06:17:36 |
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Basic information
Public title
EYE tracking technology based audio guidance of endoScopIst Gazing point for improvement of colorecTal adenoma detection A multi-center randomized trial
Acronym
EYE-SIGHT trial
Scientific Title
EYE tracking technology based audio guidance of endoScopIst Gazing point for improvement of colorecTal adenoma detection A multi-center randomized trial
Scientific Title:Acronym
EYE-SIGHT trial
Region
| Japan |
Condition
Condition
colorectal adenoma
Classification by specialty
| Gastroenterology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The adenoma detection rate (ADR) and the adenomas per colonoscopy (APC) are known as accuracy indices of colonoscopy that are directly related to reducing colorectal cancer deaths. It has been reported that educating endoscopists to take more time for observation is effective in improving ADR and APC. However, because of the variability in ADR and APC among endoscopists, quality assessment measures other than observation time are being explored even when observation time is ensured. As a candidate for a measure other than observation time, there are reports on endoscopists' visual gaze patterns. It has been shown that different endoscopists move the endoscope and gaze differently during observation and that ADR and APC are higher in endoscopists who tend to look more at the periphery of the screen than at the center during endoscope removal.
We hypothesized that specific visual gaze patterns are involved in the high adenoma detection performance. We developed an eye tracking and feedback system (ETF system) that provides endoscopists with real-time audible feedback of their gaze position during the examination and allows them to correct it. Using the ETF system, the endoscopist can set any area of the endoscope screen as the region of interest and guide the endoscopist's gaze in real-time. In a previous study, we found that the optimal setting for improving the endoscopist's APC is when the endoscope screen is divided into 36 sections of 6 x 6, and 20 sections of the peripheral area are set as the region of interest. However, this previous study was a small-scale study conducted at a single institution, and the major issue was that biases, including the Hawthorne effect, could not be avoided. Therefore, this study aims to verify whether the endoscopist's line of sight guidance using the ETF system can improve adenoma detection performance in a multicenter randomized controlled trial.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The number adenoma per patient (APC)
Key secondary outcomes
1. Adenoma detection rate (ADR)
2. Serrated lesion detection rate (SDR)
3. APC by colorectal site
4. APC by lesion diameter
5. APC by endoscopist (number and years of colonoscopy experience, certification)
6. Coordinate information on the eye position of both groups
7. Video information of both groups
8. Observation time
9. Endoscopist fatigue as measured by the visual analogue scale (VAS)
9. Number of years until the next colonoscopy in each group if the recommended post-colonoscopy surveillance plan is followed after the examination
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Placebo
Stratification
YES
Dynamic allocation
YES
Institution consideration
Institution is considered as adjustment factor in dynamic allocation.
Blocking
NO
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Maneuver |
Interventions/Control_1
Eye guidance by the ETF system
Interventions/Control_2
Control group
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
| 40 | years-old | <= |
Age-upper limit
| 90 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1. Patients who undergo colonoscopy by insurance.
2. Patients who are between 40 and 90 years old.
3. Performance status (ECOG) is between 0 (no limitation in daily life) and 1 (difficulty in physical labor but light work).
4. The patient's participation in the study has been fully explained to him/her, and his/her written consent has been obtained.
Key exclusion criteria
1. Patients with a history of surgical colorectal resection (excluding appendicectomy)
2. Patients with a history of inflammatory bowel disease (ulcerative colitis, Crohn's disease, Behcet's disease)
3. Patients with hereditary or non-hereditary gastrointestinal polyposis
5. Patients with known severe diverticular disease of the colon that makes colonoscopy difficult and dangerous
6. Patients who are unable to take bowel preparation
7. Patients who are allergic to bowel preparation agents or sedatives
8. Patients who are known in advance to have colorectal adenoma, polyp, or colorectal cancer
9. Patients who are pregnant
10. Patients who are breast-feeding
11. Patients who have not given consent to participate in the study
12. Patients who are deemed unsuitable by the study investigator
Target sample size
400
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, Chiba
TEL
047-375-1111
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, Chiba
TEL
047-375-1111
Homepage URL
ishibashi-gast@iuhw.ac.jp
Sponsor or person
Institute
International University of Health and Welfare Ichikawa Hospital
Institute
Department
Personal name
Fumiaki Ishibashi
Funding Source
Organization
Japan Science and Technology Agency
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Showa University Hospital, Tokyo Metropolitan Geriatric Hospital and Institute of Gerontology, Omori Red Cross Hospital
Name of secondary funder(s)
IRB Contact (For public release)
Organization
International University of Health and Welfare Institutional Review Board
Address
852, Hatakeda, Narita, Chiba
Tel
0476-20-7708
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 | 07 | Month | 18 | 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
Enrolling by invitation
Date of protocol fixation
| 2024 | Year | 07 | Month | 10 | Day |
Date of IRB
| 2024 | Year | 08 | Month | 19 | Day |
Anticipated trial start date
| 2024 | Year | 09 | Month | 15 | Day |
Last follow-up date
| 2025 | Year | 08 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
| 2025 | Year | 10 | Month | 31 | Day |
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2024 | Year | 07 | Month | 18 | Day |
Last modified on
| 2024 | Year | 10 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000062840
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| Registered date | File name |
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| Registered date | File name |
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