A novel colonoscope with 230-degree extra-wide field of view optics: a prospective, first-in-human pilot study

Background and aims: A model-based trial of a novel colonoscope with extra-wide field of view (EFOV) optics demonstrated a higher polyp detection rate compared to a standard colonoscope [1]. We report on the first-in-human study assessing its clinical utility. Methods: This bicentric prospective pilot trial included patients scheduled for colorectal cancer screening (CRCS), evaluation of a positive fecal immunochemical test (FIT), or polyp surveillance. The primary endpoint was the cecal intubation rate with the EFOV colonoscope. Secondary endpoints included intubation rate of the terminal ileum, procedure time, rates for detection of polyps (PDR), adenomas (ADR), sessile serrated lesions (SSLDR), adenomas per colonoscopy (APC), therapeutic success and adverse events. Results: Sixty-four patients were enrolled. Indications were CRCS (n=48) or polyp surveillance (n=16). The cecum was reached in 64 of 64 patients (100%, 95%CI 94.4 to 100.0) within a median time of 5.0 (range 2.0 to 20.0) minutes. The terminal ileum could be intubated in 96.9% (95%CI 89.2 to 99.6) of cases. Eighty-four polyps were detected and removed in 43 of 64 patients (PDR = 67%). The ADR, SSLDR and APC were 44%, 17%, and 0.81 (95%CI 0.5 to 1.1). No adverse events occurred. Conclusions: This first-in-human study shows that the EFOV colonoscope can be effectively and safely used in clinical practice. It promises improved detection of hidden polyps.