AmplifEYE Assisted Colonoscopy Versus Standard Colonoscopy: A Randomized Controlled Study.

BACKGROUND/AIMS AmplifEYE is a mucosal exposure device mounted to the tip of colonoscope to improve polyp or adenoma detection. We aim to compare the adenoma detection rates (ADR) of AmplifEYE-assisted colonoscopy (AC) with standard colonoscopy (SC). METHODS We performed a randomized controlled trial involving patients aged 50 to 79 who underwent AC or SC in two centers. Procedures were performed by five experienced colonoscopists. RESULTS 355 patients were recruited, with 334 patients (170 AC and 164 SC) included into analysis. The ADR was numerically higher in AC (47.1%) vs SC (40.9%), p = 0.253. The polyp detection rate (PDR) in AC was 68.2% vs 54.3% in SC, p = 0.009 and serrated polyp detection rate (SDR) in AC was 37.6% vs 20.1% in SC, p < 0.001, both statistically significant higher in the study group. The mean cecal intubation time was shorter with AmplifEYE (8.0 min in AC vs 8.9 min in SC, p = 0.030) and there was no difference in pain score (3 in AC vs 4 in SC, p = 0.121). CONCLUSIONS AmplifEYE-assisted colonoscopy significantly improved the PDR and SDR, while the ADR was numerically higher in AC that did not reach statistical significance. Using the device resulted in shorter cecal intubation time and did not cause more pain.