N/A
N=70
Trial Comparing Dual Probe Ultrasonic Lithotripsy to a Single Probe Ultrasonic Lithotripsy
Kidney Stones
Bottom Line
View on ClinicalTrials.gov: NCT00351351 ↗Enrolled (actual)
70
Serious AEs
0.0%
Results posted
Feb 2013
Primary outcome: Primary: Kidney Stone Clearance Rate — 61.9; 75.8 mm^2/min
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Cyberwand (Device); single probe ultrasonic (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Indiana Kidney Stone Institute
- Primary completion
- May 2008
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Kidney Stone Clearance Rate |
61.9; 75.8 | — |
Summary
Percutaneous nephrolithotomy (PNL), in conjunction with intracorporeal lithotripsy, allows for the rapid removal of any kidney stone regardless of size. Currently, the choice of intracorporeal lithotripters includes ultrasonic, pneumatic, and combined ultrasonic/pneumatic energy sources. Recently, a novel dual probe design as been introduced by Cybersonics of Erie, Pennsylvania. This dual probe intracorporeal lithotrite is called the Cyberwand, and is composed of a fixed inner probe vibrating at an ultrasonic frequency with an outer probe vibrating at about 1,000 Hz. As this new design has the potential to revolutionize intracorporeal lithotripsy, we intend to compare this novel technology to currently available lithotripsy technology in a randomized clinical trial.
Eligibility Criteria
Inclusion Criteria
- Patient of Methodist Urology in Indianapolis, IN
- Undergoing percutaneous nephrolithotomy for calculi greater than 2 cm
- Age 18 years or older
- Stone easily visible/measurable on kidney, ureters and bladder (KUB) or computed tomography (CT) scan preoperatively
Exclusion Criteria
- Radiolucent stones
- Size of largest stone less than 2 cm
- Pregnancy
- Inability to give informed consent
- Multiple percutaneous access anticipated
- Active urinary tract infection
- Recent (within last 3 months) extracorporeal shock wave lithotripsy
Data sourced from ClinicalTrials.gov (NCT00351351). 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.