Water Exchange Colonoscopy With Artificial Intelligence-assisted Detection

NACompletedINTERVENTIONAL
Enrollment

560

Participants

Timeline

Start Date

December 18, 2023

Primary Completion Date

December 5, 2024

Study Completion Date

January 5, 2025

Conditions
Colon AdenomaColonoscopyColon Polyp
Interventions
DEVICE

Water exchange alone

During the insertion phase of water exchange colonoscopy, the air pump will be turned off, while the colon will be irrigated with warm-to-touch water using a flushing pump. The water exchange approach involves the simultaneous infusion of water to facilitate luminal expansion and suction of unclean water during insertion. Upon reaching the cecum, where most of the water is suctioned to collapse the cecal lumen, the air pump will be opened. Withdrawal from the cecum will begin in the left lateral position. Similar withdrawal techniques with adequate luminal distention and comprehensive examination behind the folds will be emphasized. Any position change away from the original left lateral position in any colon segment during the withdrawal phase will be recorded. Tandem examination of specific colon segments, including the right colon, either in the standard modality or retroflexion, is prohibited.

DEVICE

Water exchange plus Artificial Intelligence (AI)

Similar water exchange technique as the active comparator will be employed during insertion. Similar withdrawal inspection techniques as the active comparator will be used. During withdrawal phase, commercially available AI system (CAD-EYE, Fujifilm, EU and Taiwan; Endo-AID, Olympus, EU and Taiwan) will be activated, providing a bounding box as output any time a lesion that is suspected to be a polyp is recognized by the AI device. False positive activation is defined as the identification by AI systems of an area during the withdrawal phase that is not deemed to be a colorectal lesion after re-examination by the colonoscopist. Real-time flagging of FP activation will be recorded by investigators and study staff.

Trial Locations (2)

320

Chi-Liang Cheng, Taoyuan District

09016

CTO Hospital, Iglesias

All Listed Sponsors
collaborator

Digestive Endoscopy Unit, CTO Hospital, Iglesias, Italy

UNKNOWN

collaborator

The Sepulveda Ambulatory Care Center, VAGLAHS, UCLA in the USA

UNKNOWN

lead

Evergreen General Hospital, Taiwan

OTHER

NCT06173258 - Water Exchange Colonoscopy With Artificial Intelligence-assisted Detection | Biotech Hunter | Biotech Hunter