Acoustic Enhancer Microbubble Cavitation: A Randomized Clinical Trial Evaluating the Safety and Efficacy of a Novel Treatment for Urolithiasis

Abstract

Purpose:The efficacy of ureteroscopy to treat urinary stones is often less than 60%. Acoustic Enhancer is an investigational device of microparticles with a tag designed with an affinity for calcium. We evaluated safety and efficacy of ureteroscopic laser lithotripsy with and without Acoustic Enhancer Microbubble Cavitation in a randomized clinical trial.Materials and Methods:Patients with urolithiasis were randomized to ureteroscopic laser lithotripsy with or without Acoustic Enhancer. The end points were the proportion of patients without residual fragments ≥ 2 mm on CT 30 days post procedure (fragment-free rate) and adverse events (AEs).Results:There were 103 and 93 patients in the investigational and control groups, respectively. There was no statistical superiority between the 2 groups. The fragment-free rate was 41% and 47% in the investigational and control groups, respectively (P =.46). Residual fragment size was similar, 5.55 mm vs 5.70 mm for the investigational and control groups, respectively (P =.71). Among investigational patients treated with higher average powers ≥ 12 W, the fragment-free rate was 51% compared with 32% (n = 47) for the low-power group (P =.06). AEs were noted in 35% and 46% of patients in the investigational and control groups, respectively (P =.11). The total number of AEs was less for the investigational arm (P