Overview

This trial is active, not recruiting.

Condition kidney stones
Treatments cyberwand, stonebreaker, lithoclast select
Sponsor Indiana Kidney Stone Institute
Start date August 2009
End date October 2016
Trial size 270 participants
Trial identifier NCT00952315, 09-045

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Intervention model factorial assignment
Masking single blind (subject)
Primary purpose treatment
Arm
(Active Comparator)
Stonebreaker will be used to break up the kidney stone. Duration will be timed and documented.
stonebreaker
Stonebreaker will be used to break up the kidney stone. Duration will be timed and documented.
(Active Comparator)
Lithoclast Select will be used to breakup and remove kidney stone. Duration will be timed and documented.
lithoclast select
Lithoclast Select will be used to break up and remove the kidney stone. Duration will be timed and documented
(Active Comparator)
The dual probe Cyberwand device will be used to fragment and remove the kidney stone. Duration will be timed and documented.
cyberwand
Dual probe lithotrite Cyberwand will be used to remove kidney stone. Duration will be timed and documented.

Primary Outcomes

Measure
Time to removal of a single, targeted kidney stone
time frame: 1 - 3 months

Secondary Outcomes

Measure
Device complications such as probes clogging or breaking
time frame: 1-3 months

Eligibility Criteria

Male or female participants at least 18 years old.

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

Additional Information

Official title Randomized Controlled Trial Comparing Three Different Modalities of Newer Lithotrites For Intracorporeal Lithotripsy
Principal investigator James E Lingeman, MD
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.
Trial information was received from ClinicalTrials.gov and was last updated in June 2016.
Information provided to ClinicalTrials.gov by Indiana Kidney Stone Institute.