NCT07127471 Computer-Aided Water Exchange Colonoscopy With and Without Linked-Color Imaging for Detection of Clinically Significant Serrated Lesions
| NCT ID | NCT07127471 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Evergreen General Hospital, Taiwan |
| Condition | Sessile Colonic Polyp |
| Study Type | INTERVENTIONAL |
| Enrollment | 1,090 participants |
| Start Date | 2025-11-17 |
| Primary Completion | 2027-04-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 1,090 participants in total. It began in 2025-11-17 with a primary completion date of 2027-04-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The goal of this clinical trial is to compare the detection rate of clinically significant serrated lesions (CSSL) in participants undergoing water exchange (WE) colonoscopy with artificial intelligence (AI)-based computer-aided detection (CADe) for screening, surveillance, diagnosis for symptoms, or referred owing to a positive fecal immunochemical test (FIT) or guaiac fecal occult blood test (gFOBT) result. There will be two arms in this study: WE with AI-assisted CADe (WEAID) control and WEAID plus linked-color imaging (LCI). The main question it aims to answer is whether the addition of LCI into WEAID colonoscopy increases CSSL detection rate. Both groups use water instead of air to insert the colonoscope into the cecum. The control method uses CADe to help detect colonic lesions. The study method uses a combination of CADe and LCI to detect lesions. Researchers will compare CSSL detection rate to see if the addition of LCI increases the detection of CSSL during CADe-assisted WE colonoscopy.
Eligibility Criteria
Inclusion Criteria: * Male and female patients aged 40-80 years scheduled for average-risk screening colonoscopy, post-polypectomy surveillance, diagnosis for gastrointestinal symptoms (including unexplained iron deficiency anemia and clinically significant diarrhea of unexplained origin), or referred for colonoscopy owing to a positive fecal immunochemical test (FIT) or guaiac fecal occult blood test (gFOBT) result. Exclusion Criteria: * familial adenomatous polyposis and hereditary non-polyposis CRC syndrome * personal history of serrated polyposis syndrome * personal history of CRC * history of inflammatory bowel disease * previous colonic resection * overt gastrointestinal bleeding * emergency colonoscopy or inpatients * planned EMR or ESD of large polyps * colon stricture or obstruction * contraindications to colonoscopy (eg, acute diverticulitis or toxic megacolon) * antithrombotic therapy precluding complete polyp resection * American Society of Anesthesiology classification of physical status \>3 * pregnant women or women planning pregnancy * refusal to provide a written informed consent
Contact & Investigator
Chi-Liang Cheng, MD
STUDY CHAIR
Evergreen General Hospital, Taoyuan
Frequently Asked Questions
Who can join the NCT07127471 clinical trial?
This trial is open to participants of all sexes, aged 40 Years or older, up to 80 Years, studying Sessile Colonic Polyp. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07127471 currently recruiting?
Yes, NCT07127471 is actively recruiting participants. Contact the research team at chiliang.cheng@gmail.com for enrollment information.
Where is the NCT07127471 trial being conducted?
This trial is being conducted at Montreal, Canada, Como, Italy, Taoyuan, Taiwan, Bangkok, Thailand.
Who is sponsoring the NCT07127471 clinical trial?
NCT07127471 is sponsored by Evergreen General Hospital, Taiwan. The principal investigator is Chi-Liang Cheng, MD at Evergreen General Hospital, Taoyuan. The trial plans to enroll 1,090 participants.