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

Completed · Not applicable

Conditions studied: Kidney Calculi

In brief

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

Key facts

Study ID

NCT03959683

Run by

Indiana University

People needed

100

Starts

2019-02-19

Expected to finish

2020-11-18

Last updated by the study team

2023-04-12

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• ≥ 18 years of age
• At least one renal stone > 1.5 cm in maximum diameter as measured on preoperative CT scan
• Patient is scheduled to undergo a percutaneous nephrolithotomy procedure
• Willing and able to provide informed consent

You may not qualify if…

• Pregnant
• Active urinary tract infection
• Prior shock wave lithotripsy within 3 months of study procedure
• Multiple percutaneous access sites are anticipated
• Unable or unwilling to provide informed consent -

Where it is running

• Mayo Clinic Hospital — Phoenix, Arizona, United States
• Indiana University Health Physicians Urology — Indianapolis, Indiana, United States
• The Ohio State University — Columbus, Ohio, United States
• The University of British Columbia — Vancouver, British Columbia, Canada

Full record on ClinicalTrials.gov

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