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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age40-80
SponsorEvergreen General Hospital, Taiwan

About this trial

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

Qualifiers

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.

Disqualifiers

familial adenomatous polyposis and hereditary non-polyposis CRC syndrome

personal history of serrated polyposis syndrome

personal history of CRC

history of inflammatory bowel disease

Trial design

Treatments tested in this trial

  • Water exchange with AI-assisted detection
  • Water exchange with AI-assisted detection and LCI

Treatment groups

1,090 Participants
are divided into 2 treatment groups

Sponsors and collaborators

Evergreen General Hospital, Taiwan

Lead sponsor

Centre hospitalier de l'Université de Montréal (CHUM)

Collaborator

King Chulalongkorn Memorial Hospital

Collaborator

Valduce Hospital

Collaborator