ShockPulse-SE vs. Trilogy Trial: Comparing the Performance of Two Intracorporeal Lithotripters for Removal of Large Renal Calculi

NACompletedINTERVENTIONAL
Enrollment

100

Participants

Timeline

Start Date

February 19, 2019

Primary Completion Date

July 29, 2020

Study Completion Date

November 18, 2020

Conditions
Kidney Calculi
Interventions
DEVICE

Trilogy Lithotrite

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.

DEVICE

The ShockPulse-SE Lithotripsy System

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.

Trial Locations (4)

43212

The Ohio State University, Columbus

46202

Indiana University Health Physicians Urology, Indianapolis

85054

Mayo Clinic Hospital, Phoenix

V5Z 1M9

The University of British Columbia, Vancouver

All Listed Sponsors
collaborator

Boston Scientific Corporation

INDUSTRY

collaborator

Ohio State University

OTHER

collaborator

Mayo Clinic

OTHER

collaborator

University of British Columbia

OTHER

lead

Indiana University

OTHER

NCT03959683 - ShockPulse-SE vs. Trilogy Trial: Comparing the Performance of Two Intracorporeal Lithotripters for Removal of Large Renal Calculi | Biotech Hunter | Biotech Hunter