At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Prospective Randomized Multicenter Trial Comparing Performance of Two Intracorporeal Lithotripters for Removal of Large Renal Calculi
In Brief
A clinical study evaluating Trilogy Lithotrite and The ShockPulse-SE Lithotripsy System for Kidney Calculi. Completed, enrolled 100 participants across 4 sites in 2 countries.
Detailed Summary
The purpose of this study is to measure how well two different devices work to break up and remove kidney stones. We are comparing a newer device to an older one to see which one is faster at breaking up kidney stones. We hypothesize that the Trilogy will increase the stone clearance rate by 25% compared to the Shockpulse-SE
Study Details
Timeline
Interventions
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.
The ShockPulse-SE System is an electromechanical device capable of fragmenting calculi and aspirating stone debris. The novel technology in the ShockPulse-SE Lithotripsy System uses a single transducer and proprietary ShockPulse technology to generate both low-frequency mechanical impacts and high-frequency ultrasonic energy which quickly disintegrates stones.