CVAC Aspiration System achieves 96% stone clearance in small renal stone evacuation study

This prospective, single-arm study evaluated the safety and effectiveness of the second-generation CVAC Aspiration System for steerable ureteroscopic renal evacuation in 30 subjects with renal stones. Of the enrolled subjects, 26 had evaluable noncontrast CT (NCCT) data at postoperative day 30. The mean baseline stone volume was 703.6 mm³, and mean stone density was 1203 HU.

The primary outcomes were stone clearance, residual stone volume (RSV), and stone-free rate (SFR). The mean stone clearance was 96.2%, and the average RSV was 14.1 mm³. The SFR, defined as zero residual fragments, was 46.4%. The study reported that stone clearance remained high and RSV remained low even with increasing baseline stone volume.

Regarding safety, there were two instances of urinary tract infection (Clavien-Dindo grade II). No subjects required intervention or retreatment. Key limitations include the single-arm design without a comparator, the absence of 4 subjects from the POD 30 analysis, and a strict definition of stone-free status. The practice relevance is limited as this is an early, uncontrolled evaluation of a specific device.