To evaluate the safety and effectiveness of the second-generation CVAC® Aspiration System.
Methods:
A prospective study of steerable ureteroscopic renal evacuation using the second-generation CVAC was performed. Stone clearance (percent stone volume removed), residual stone volume (RSV), and stone-free rate (SFR) at postoperative day 30 were assessed using noncontrast CT (NCCT). Adverse events were recorded.
Results:
Twenty-six out of 30 subjects had POD 30 NCCT. Mean baseline stone volume and density were 703.6 mm3 and 1203 HU, respectively. Mean stone clearance was 96.2%; average RSV was 14.1 mm3, and SFR (zero residual fragments) was 46.4%. Stone clearance remained high, and RSV remained low with increasing baseline stone volume. There were two instances of urinary tract infection (Clavien-Dindo grade II) and no subjects requiring intervention or retreatment.
Conclusions:
The CVAC Aspiration System safely delivers high stone clearance and low RSV.
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