This clinical trial evaluates the effect of real-time feedback (RTFB) during colonoscopy or endoscopy. Using an RTFB infrastructure, where computer algorithms generate quality-related metrics during colonoscopy, the endoscopist is informed about specific quality-related features. This may allow for an immediate response by the endoscopist when the quality is low and can provide positive feedback when the quality is high.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT05241210.
PRIMARY OBJECTIVES:
I. To implement the video file capture and storage environment required as the basis for Phase 2-3 (Phase 1).
II. To test individual RTFB components (Phase 2).
III. To combine the optimal format of all RTFB components and determine their effect on quality (Phase 3).
SECONDARY OBJECTIVES:
I. To test the capture system and improve it so that near 100% uptime and data capture occur (Phase 1).
II. To determine relationship between quality and adenoma detection rate (ADR) (Phase 3).
OUTLINE:
PHASE 1: Patients undergo capturing of "inside-the-patient only" images during standard colonoscopy on study.
PHASE 2-3: Endoscopists receive RTFB if the images suggest sub-optimal performance during colonoscopy on study.
Trial PhaseNo phase specified
Trial Typescreening
Lead OrganizationUniversity of Minnesota/Masonic Cancer Center
Principal InvestigatorPetrus (Piet) Cornelius de Groen
