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Computer-Aided Water Exchange Colonoscopy With and Without Linked-Color Imaging for Detection of Clinically Significant Serrated Lesions

StatusRecruiting
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 5 months later Apr 30, 2027 → Sep 30, 2027
See other at-risk trials from Evergreen General Hospital, Taiwan

Record History

See every version on ClinicalTrials.gov ↗

  1. Primary completion pushed from Apr 30, 2027 to Sep 30, 2027
    • Study completion pushed from Jul 31, 2027 to Dec 31, 2027
    v4
  2. Trial status: Not Yet Recruiting to Recruiting
    • Start date changed from estimate of Nov 1, 2025 to Nov 17, 2025
    • Site details revised at 4 of 4 sites
    v3
  3. Start date: Oct 1, 2025 to Nov 1, 2025v2 Show 7 more changesShow less
    • Enrollment target: 872 to 1090
    • Study sites: 2 to 4
    • Primary completion date: Jul 31, 2027 to Apr 30, 2027
    • Study completion date: Sep 30, 2027 to Jul 31, 2027
    • Study description expanded, about 7 words
    • Collaborators: 1 to 3
    • Study title shortened, about 1 word
  4. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT07127471
Lead Sponsor Evergreen General Hospital, Taiwan
Collaborators: Centre hospitalier de l'Université de Montréal (CHUM), King Chulalongkorn Memorial Hospital, Valduce Hospital
Conditions
(from sponsor)		 Sessile Colonic Polyp, Serrated Lesion, Sessile Serrated Lesion, Colon Adenomas
Enrollment 1,090 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov