A Prospective Randomized Multicenter Trial Comparing Performance of Two Intracorporeal Lithotripters for Removal of Large Renal Calculi

Large and complex renal calculi, defined as those with a maximum diameter of ≥ 1.5 cm, can be removed from the upper urinary tract by percutaneous nephrolithotomy but the stones usually require fragmentation in order to remove them through the access site. There are a number of commercially available intracorporeal lithotripters used to fragment or break kidney stones to allow elimination including pneumatic, ultrasonic, and combination devices. Each technology has its own relative advantages and disadvantages.

New versions of intracorporeal lithotripter devices have been introduced with improvements meant to address prior functional limitations such as probe clogging or breaking and cumbersome hand piece design.

The Trilogy lithotrite is the newest generation device stone fragmentation device from Boston Scientific. The Trilogy device uses unique technology to efficiently fragment and remove stone material, superior to other devices on the market based on preliminary bench testing. From Olympus, the ShockPulse-SE Lithotripsy System (Cybersonics, Erie, PA, USA) is a constant ultrasonic wave energy lithotripter with intermittent shock wave (ballistic/mechanical) energy. The ShockPulse-SE has a single probe design with an OD of 3.76 mm which allows for larger sized stone fragments to be vacuumed from the urothelium. The larger, single lumen also allows for a high flow rate to reduce probe clogging events. The end result is faster stone clearance rates based on in vitro studies.

The objective of this study is to compare the performance, as measured by the stone clearance rate at time of percutaneous nephrolithotomy, of the ShockPulse-SE Lithotripsy System to the Trilogy lithotrite when used for large complex renal calculi.

The Trilogy has been FDA cleared for fragmentation of urinary tract calculi in the kidney, ureter, and bladder. Trilogy is a combined piezoelectric/pneumatic device capable of fragmenting calculi and aspirating stone debris. The novel technology in Trilogy has been demonstrated in bench testing to more quickly disintegrate stones compared to other devices.