N/A
N=100
ShockPulse-SE vs. Trilogy Trial: Comparing the Performance of Two Intracorporeal Lithotripters for Removal of Large Renal Calculi
Kidney Calculi
Bottom Line
View on ClinicalTrials.gov: NCT03959683 ↗Enrolled (actual)
100
Serious AEs
0.0%
Results posted
Apr 2023
Primary outcome: Primary: Stone Clearance Rate Defined as the Kidney Stone Surface Area Measured by Pre-operative Computed Tomography (CT) Scan Divided by the Time to Remove the Targeted Stone Burden. — 1.22; 0.77 cm^3/min
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Trilogy Lithotrite (Device); The ShockPulse-SE Lithotripsy System (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Indiana University
- Primary completion
- Jul 2020
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Stone Clearance Rate Defined as the Kidney Stone Surface Area Measured by Pre-operative Computed Tomography (CT) Scan Divided by the Time to Remove the Targeted Stone Burden. |
1.22; 0.77 | — |
| SECONDARY Device Malfunctions During Intraoperative Device Use as Described by Surgeon Completing the Device Questionnaire. |
1; 17 | — |
| SECONDARY All Complications Measured by the Clavien Classification of Surgical Complications |
1; 5; 2; 3; 3; 1 | — |
| SECONDARY Number of Participants With Stone Free Status as Defined by the Presence or Absence of Stone Material on Postoperative CT Imaging and at Final Follow up |
46; 44 | — |
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
Eligibility Criteria
Inclusion Criteria
- ≥ 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
Exclusion Criteria
- 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 -
Data sourced from ClinicalTrials.gov (NCT03959683). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.