NCT00952315

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

Randomized Controlled Trial Comparing Three Different Modalities of Newer Lithotrites For Intracorporeal Lithotripsy

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 270 (actual)
• Sponsor: Indiana Kidney Stone Institute · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Kidney Stones

Interventions

Type	Name	Description
DEVICE	Cyberwand	Dual probe lithotrite Cyberwand will be used to remove kidney stone. Duration will be timed and documented.
DEVICE	Stonebreaker	Stonebreaker will be used to break up the kidney stone. Duration will be timed and documented.
DEVICE	Lithoclast Select	Lithoclast Select will be used to break up and remove the kidney stone. Duration will be timed and documented

Timeline

• Start date: 2009-08-01
• Primary completion: 2016-10-01
• Completion: 2017-02-01
• First posted: 2009-08-06
• Last updated: 2019-07-05
• Results posted: 2019-07-05

Locations

10 sites across 2 countries: United States, Canada