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EYE tracking technology based audio guidance of endoScopIst Gazing point for improvement of colorecTal adenoma detection A multi-center randomized trial

EYE tracking technology based audio guidance of endoScopIst Gazing point for improvement of colorecTal adenoma detection A multi-center randomized trial - EYE-SIGHT trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000055006
Enrollment
400
Registered
2024-07-18
Start date
2024-09-15
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

colorectal adenoma

Interventions

Eye guidance by the ETF system Control group

Sponsors

International University of Health and Welfare Ichikawa Hospital
Lead Sponsor
Showa University Hospital, Tokyo Metropolitan Geriatric Hospital and Institute of Gerontology, Omori Red Cross Hospital
Collaborator

Eligibility

Sex/Gender
All

Inclusion criteria

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.

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frame
The number adenoma per patient (APC)

Secondary

MeasureTime frame
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

Countries

Japan

Contacts

Public ContactFumiaki Ishibashi

International University of Health and Welfare Ichikawa Hospital Department of Gastroenterology

ishibashi-gast@iuhw.ac.jp047-375-1111

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026