Cyberwand
DeviceDual probe lithotrite Cyberwand will be used to remove kidney stone. Duration will be timed and documented.
NCT Number: NCT00952315
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.
Looking for future studies?
Notify Me18 year and older
All sexes
Interventional
Not applicable
University of British Columbia, Vancouver, British Columbia, Canada
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Dual probe lithotrite Cyberwand will be used to remove kidney stone. Duration will be timed and documented.
Stonebreaker will be used to break up the kidney stone. Duration will be timed and documented.
Lithoclast Select will be used to break up and remove the kidney stone. Duration will be timed and documented
Time frame: 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)
Time frame: Post-operative Day 1
Number of participants deemed stone-free after initial stone-removal surgery
Time frame: Within three days of initial procedure
Number of participants who required a secondary kidney stone removal procedure
Time frame: Intra-operatively
Participants requiring a ureteral stent to be placed after initial stone removal procedure
Time frame: Intra-operatively
Participants requiring a nephrostomy tube to be placed at the end of the initial stone removal procedure
Time frame: Intra-operatively
Number of participants in which another stone breakage device was used in addition to the study-assigned lithotrite
Time frame: Intra-operatively
Number of participants with an estimated blood loss greater than 400mL
Time frame: Post-operatively <24 hours
Number of participants who required a blood transfusion post-operatively
Time frame: Post-operatively
Number of days participants were in hospital. Operative day is Day 1.
Time frame: Post-operative Days 2 and 3
Number of participants who experienced surgery-related post-op complications
Indiana Kidney Stone Institute
Other
Randomized Controlled Trial Comparing Three Different Modalities of Newer Lithotrites For Intracorporeal Lithotripsy
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT02214836
Calculi, Female Urogenital Diseases
Seattle, Washington, United States
View Trial DetailsNCT07159035
Calculi, Female Urogenital Diseases
Guangzhou, Guangdong, China
View Trial DetailsNCT07377461
Calculi, Female Urogenital Diseases
Ashkelon, Israel
View Trial DetailsNCT01835600
Calculi, Female Urogenital Diseases
Shanghai, Shanghai Municipality, China
View Trial Details