Randomized Controlled Trial Comparing Three Different Modalities of Newer Lithotrites For Intracorporeal Lithotripsy
Phoenix/Scottsdale, Ariz., Rochester, Minn.
Trial status: Open for Enrollment
Why is this study being done?
Large kidney stones can be removed by a surgical procedure where a small puncture is made through the back into the kidney (percutaneous nephrolithotomy or PNL) but the stones usually need to be broken into smaller pieces before they can be removed through the small surgical incision. There are a number of FDA approved devices commercially available used to break up the stones including pneumatic, ultrasonic, and a combination of the two. Each technology has advantages and disadvantages.
In the last few years there have been new, improved versions of these devices introduced. These improved versions have addressed previous issues of probes clogging or breaking and cumbersome handpiece design. These include the Cyberwand (Cybersonics, Erie, PA), a dual probe ultrasonic device, Swiss Lithoclast Select (EMS, Switzerland) combining the pneumatic and ultrasonic modalities, and a novel device by LMA (Gland, Switzerland) called the StoneBreakerTM, a portable pneumatic device powered by CO2 cartridges.
We propose to compare each of these devices in a randomized study to see if one is better than another at removing kidney stones quickly and efficiently.
Who is eligible to participate?
- Scheduled to undergo percutaneous nephrolithotomy for at least one kidney stone measuring 2 cm or greater
- Stone easily visible/measurable on plain abdominal imaging (KUB) or CT scan preoperatively
- Age 18 years or older
- Able to give informed consent
- Size of single largest stone less than 2 cm
- Active urinary tract infection
- Extracorporeal shockwave lithotripsy within the last three months
- Complex stone anticipating multiple access sites
- Stones that are not clearly able to be measured on KUB or CT scan
- Inability to give informed consent
- Age less than 18 years