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

Kidney Stones Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00952315
• Other study ID #: 09-045
• Status: Completed
• Phase: N/A
• Start date: August 2009
• Est. completion date: February 2017

Study information

• Verified date: June 2019
• Source: Indiana Kidney Stone Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 270
• Est. completion date: February 2017
• Est. primary completion date: October 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

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:

• 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

Related Conditions & MeSH terms

• Kidney Calculi
• Kidney Stones
• Nephrolithiasis

Intervention

Device:
• Cyberwand
Dual probe lithotrite Cyberwand will be used to remove 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.
• Lithoclast Select
Lithoclast Select will be used to break up and remove the kidney stone. Duration will be timed and documented

Locations

Country	Name	City	State
Canada	The University of Western Ontario	London	Ontario
Canada	University of British Columbia	Vancouver	British Columbia
United States	Johns Hopkins	Baltimore	Maryland
United States	Northwestern University	Chicago	Illinois
United States	Duke University	Durham	North Carolina
United States	IU Health Physicians Urology	Indianapolis	Indiana
United States	University of Wisconsin	Madison	Wisconsin
United States	Vanderbilt University Medical Center	Nashville	Tennessee
United States	Mayo Clinic Scottsdale	Phoenix	Arizona
United States	Mayo Clinic Rochester	Rochester	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
Indiana Kidney Stone Institute

Countries where clinical trial is conducted

United States,  Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Stone Clearance Time in mm2/Min	Clearance rate was calculated by dividing the surface area of the targeted stone (mm2) by the total clearance time (min)	collected intraoperatively from the time stone breakage begins to end of stone removal with a stone extraction basket
Secondary	Stone-free After First Procedure	Number of participants deemed stone-free after initial stone-removal surgery	Post-operative Day 1
Secondary	Secondary Procedure Required	Number of participants who required a secondary kidney stone removal procedure	Within three days of initial procedure
Secondary	Ureteral Stent Placed	Participants requiring a ureteral stent to be placed after initial stone removal procedure	Intra-operatively
Secondary	Nephrostomy Tube Placed	Participants requiring a nephrostomy tube to be placed at the end of the initial stone removal procedure	Intra-operatively
Secondary	Use of Other Device	Number of participants in which another stone breakage device was used in addition to the study-assigned lithotrite	Intra-operatively
Secondary	EBL>400mL	Number of participants with an estimated blood loss greater than 400mL	Intra-operatively
Secondary	RBC Transfusion	Number of participants who required a blood transfusion post-operatively	Post-operatively <24 hours
Secondary	Length of Stay	Number of days participants were in hospital. Operative day is Day 1.	Post-operatively
Secondary	Post-operative Complications	Number of participants who experienced surgery-related post-op complications	Post-operative Days 2 and 3

External Links

•   International Kidney Stone Institute - Click here for more information about kidney stone disease