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

Indiana Kidney Stone Institute

Status: Completed

Conditions: Kidney Stones

Treatments: Device: Lithoclast Select; Device: Stonebreaker; Device: Cyberwand

Study type: Interventional

Funder types: Other

Identifiers

NCT00952315

09-045

Details and patient eligibility

About

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.

Full 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.

Enrollment: 270 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

• Size of single largest stone less than 2 cm
• Pregnancy
• 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: Single Blind

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270 participants in 3 patient groups

Stonebreaker

Active Comparator group

Description:

Stonebreaker will be used to break up the kidney stone. Duration will be timed and documented.

Treatment:

Device: Stonebreaker

Lithoclast Select

Active Comparator group

Description:

Lithoclast Select will be used to breakup and remove kidney stone. Duration will be timed and documented.

Treatment:

Device: Lithoclast Select

Cyberwand

Active Comparator group

Description:

The dual probe Cyberwand device will be used to fragment and remove the kidney stone. Duration will be timed and documented.

Treatment:

Device: Cyberwand