Trial Comparing Three Different Devices for Kidney Stone Removal During Percutaneous Surgery

Not Applicable

Completed

Interventions: Device: Stonebreaker
Device: Lithoclast Select
Device: Cyberwand

Brief Summary: The investigators plan to compare three different devices that are used to break up large kidney stones during surgery for removal to see if one is faster or more efficient than the others.

Detailed Description: 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.

Recruitment & Eligibility

Inclusion Criteria

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

Exclusion Criteria

Arm && Interventions

Group	Intervention	Description
Stonebreaker	Stonebreaker	Stonebreaker will be used to break up the kidney stone. Duration will be timed and documented.
Lithoclast Select	Lithoclast Select	Lithoclast Select will be used to breakup and remove kidney stone. Duration will be timed and documented.
Cyberwand	Cyberwand	The dual probe Cyberwand device will be used to fragment and remove the kidney stone. Duration will be timed and documented.

Primary Outcome Measures

Name	Time	Method
Stone Clearance Time in mm2/Min	collected intraoperatively from the time stone breakage begins to end of stone removal with a stone extraction basket	Clearance rate was calculated by dividing the surface area of the targeted stone (mm2) by the total clearance time (min)

Secondary Outcome Measures

Name	Time	Method
Stone-free After First Procedure	Post-operative Day 1	Number of participants deemed stone-free after initial stone-removal surgery
Secondary Procedure Required	Within three days of initial procedure	Number of participants who required a secondary kidney stone removal procedure
Ureteral Stent Placed	Intra-operatively	Participants requiring a ureteral stent to be placed after initial stone removal procedure
Length of Stay	Post-operatively	Number of days participants were in hospital. Operative day is Day 1.
Post-operative Complications	Post-operative Days 2 and 3	Number of participants who experienced surgery-related post-op complications
EBL>400mL	Intra-operatively	Number of participants with an estimated blood loss greater than 400mL
Nephrostomy Tube Placed	Intra-operatively	Participants requiring a nephrostomy tube to be placed at the end of the initial stone removal procedure
Use of Other Device	Intra-operatively	Number of participants in which another stone breakage device was used in addition to the study-assigned lithotrite
RBC Transfusion	Post-operatively <24 hours	Number of participants who required a blood transfusion post-operatively

Locations (10): Mayo Clinic Scottsdale
🇺🇸
Phoenix, Arizona, United States
University of Wisconsin
🇺🇸
Madison, Wisconsin, United States
IU Health Physicians Urology
🇺🇸
Indianapolis, Indiana, United States
University of British Columbia
🇨🇦
Vancouver, British Columbia, Canada
Mayo Clinic Rochester
🇺🇸
Rochester, Minnesota, United States
Northwestern University
🇺🇸
Chicago, Illinois, United States
Johns Hopkins
🇺🇸
Baltimore, Maryland, United States
Duke University
🇺🇸
Durham, North Carolina, United States
Vanderbilt University Medical Center
🇺🇸
Nashville, Tennessee, United States
The University of Western Ontario
🇨🇦
London, Ontario, Canada