Efficacy of EndoBRAIN-EYE for detection of colorectal neoplasia: an open-label randomized control trial

Efficacy of EndoBRAIN-EYE for detection of colorectal neoplasia: an open-label randomized control trial - EYE-OPENER trial

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000049054

Enrollment

1000

Registered

2022-09-28

Start date

2022-09-28

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

Adenoma

Interventions

Colonoscopy with EndoBRAIN-EYE Colonoscopy without EndoBRAIN-EYE

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. 40 years old or more 2. Colonoscopy for CRC screening, post-polypectomy surveillance, FIT positivity, or symptom/signs 3. Consent for polypectomy

Exclusion criteria

Exclusion criteria: 1. Patients with a history of CRC (T1 or deeper) 2. Patients with a history of bowel resection 3. Patients with inflammatory bowel disease 4. Patients with colorectal polyposis 5. Patients who take antithrombotic medications and cannot be withdrawn from them

Design outcomes

Primary

Measure	Time frame
Adenoma detection rate: ADR	—

Secondary

Measure	Time frame
1. Proximal ADR 2. Adenoma per colonoscopy 3. Sessile serrated lesion detection rate: SDR 4. Proximal SDR 5. Sessile serrated lesion per colonoscopy 6. Advanced adenoma detection rate 7. Advanced adenoma per colonoscopy 8. Advanced neoplasia detection rate 9. Advanced neoplasia per colonoscopy 10. Total number of adenomas and sessile serrated lesions 11. Non-neoplastic resection rate 12. Insertion time 13. Observation time	—

Measure

Time frame

1. Proximal ADR 2. Adenoma per colonoscopy 3. Sessile serrated lesion detection rate: SDR 4. Proximal SDR 5. Sessile serrated lesion per colonoscopy 6. Advanced adenoma detection rate 7. Advanced adenoma per colonoscopy 8. Advanced neoplasia detection rate 9. Advanced neoplasia per colonoscopy 10. Total number of adenomas and sessile serrated lesions 11. Non-neoplastic resection rate 12. Insertion time 13. Observation time

—

Countries

Japan

Contacts

Public ContactYohei Yabuuchi

Kobe City Medical Center General Hospital Department of Gastroenterology

yohei_yabuuchi@kcho.jp078-302-4321

Outcome results

None listed

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