Trial Comparing Dual Probe Ultrasonic Lithotripsy to a Single Probe Ultrasonic Lithotripsy

Kidney Stones Clinical Trial

Official title:

Randomized Control Trial Comparing Dual Probe Ultrasonic Lithotripsy to a Single Probe Ultrasonic Lithotripsy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00351351
• Other study ID #: 06-035
• Status: Completed
• Phase: N/A
• First received: July 11, 2006
• Last updated: February 22, 2013
• Start date: July 2006
• Est. completion date: May 2008

Study information

• Verified date: February 2013
• Source: Indiana Kidney Stone Institute
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

Percutaneous nephrolithotomy (PNL), in conjunction with intracorporeal lithotripsy, allows for the rapid removal of any kidney stone regardless of size. Currently, the choice of intracorporeal lithotripters includes ultrasonic, pneumatic, and combined ultrasonic/pneumatic energy sources. Recently, a novel dual probe design as been introduced by Cybersonics of Erie, Pennsylvania. This dual probe intracorporeal lithotrite is called the Cyberwand, and is composed of a fixed inner probe vibrating at an ultrasonic frequency with an outer probe vibrating at about 1,000 Hz. As this new design has the potential to revolutionize intracorporeal lithotripsy, we intend to compare this novel technology to currently available lithotripsy technology in a randomized clinical trial.

Description:

Percutaneous nephrolithotomy (PNL) is used to remove large and complex stones from the upper urinary tract. Intracorporeal lithotripsy is an integral part of PNL. Commercially available intracorporeal lithotripsy modalities include ultrasonic, pneumatic, and combined ultrasonic and pneumatic models. Each modality has its inherent advantages and disadvantages. Ultrasonic lithotrites are capable of fragmenting stones while concomitantly suctioning out fragments. Unfortunately some stones are hard enough to resist fragmentation from ultrasonic lithotripsy. Pneumatic lithotrites are able to fragment all stones regardless of hardness, but this modality is unable to suction out stone pieces at the same time fragmentation is occurring. The newest lithotrite which combines both ultrasonic and pneumatic components is capable of fragmenting any stone, but also has some inherent limitations. The handpiece of the lithotripsy device is somewhat cumbersome, the suction component can clog, and the device has overheated at the maximal settings (Kuo et al). Current intracorporeal lithotrites, while functional, can certainly be improved.

Recently, a novel dual probe design has been introduced by Cybersonics of Erie, PA. This dual probe intracorporeal lithotrite is called the Cyberwand and is composed of a fixed inner probe vibrating at an ultrasonic frequency with an outer probe vibrating at about 1,000 Hz. As this new design has the potential to revolutionalize intracorporeal lithotripsy, we intend to compare this novel technology to currently available lithotripsy technology in a randomized clinical trial.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 70
• Est. completion date: May 2008
• Est. primary completion date: May 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patient of Methodist Urology in Indianapolis, IN

• Undergoing percutaneous nephrolithotomy for calculi greater than 2 cm

• Age 18 years or older

• Stone easily visible/measurable on kidney, ureters and bladder (KUB) or computed tomography (CT) scan preoperatively

Exclusion Criteria:

• Radiolucent stones

• Size of largest stone less than 2 cm

• Pregnancy

• Inability to give informed consent

• Multiple percutaneous access anticipated

• Active urinary tract infection

• Recent (within last 3 months) extracorporeal shock wave lithotripsy

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Kidney Calculi
• Kidney Stones
• Nephrolithiasis

Intervention

Device:
• Cyberwand
FDA approved - dual probe intracorporeal lithotrite
• single probe ultrasonic
FDA-approved - single probe ultrasonic

Locations

Country	Name	City	State
Canada	University of Western Ontario - St. Joseph's Hospital	London	Ontario
Canada	Vancouver Hospital	Vancouver	British Columbia
United States	John's Hopkins University	Baltimore	Maryland
United States	Northwestern University Dept. of Urology	Chicago	Illinois
United States	Duke University	Durham	North Carolina
United States	Methodist Hospital	Indianapolis	Indiana
United States	University of Wisconsin	Madison	Wisconsin

Sponsors (1)

Lead Sponsor	Collaborator
Indiana Kidney Stone Institute

Countries where clinical trial is conducted

United States,  Canada, 

References & Publications (1)

Kuo RL, Paterson RF, Siqueira TM Jr, Evan AP, McAteer JA, Williams JC Jr, Lingeman JE. In vitro assessment of lithoclast ultra intracorporeal lithotripter. J Endourol. 2004 Mar;18(2):153-6. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Kidney Stone Clearance Rate	stone clearance rate calculated in mm^2/min per protocol specification	6 months	No