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Sponsored by: |
Indiana Kidney Stone Institute |
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Information provided by: | Indiana Kidney Stone Institute |
ClinicalTrials.gov Identifier: | NCT00351351 |
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.
Condition | Intervention |
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Kidney Stones |
Device: Cyberwand Device: single probe ultrasonic |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment |
Official Title: | Randomized Control Trial Comparing Dual Probe Ultrasonic Lithotripsy to a Single Probe Ultrasonic Lithotripsy |
Enrollment: | 70 |
Study Start Date: | July 2006 |
Study Completion Date: | May 2008 |
Primary Completion Date: | May 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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A: Experimental
Cyberwand
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Device: Cyberwand
FDA approved - dual probe intracorporeal lithotrite
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B: Active Comparator
Currently available lithotripsy technology
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Device: single probe ultrasonic
FDA-approved - single probe ultrasonic
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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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
United States, Illinois | |
Northwestern University Dept. of Urology | |
Chicago, Illinois, United States, 60611 | |
United States, Indiana | |
Methodist Hospital | |
Indianapolis, Indiana, United States, 46202 | |
United States, Maryland | |
John's Hopkins University | |
Baltimore, Maryland, United States | |
United States, North Carolina | |
Duke University | |
Durham, North Carolina, United States, 27710 | |
United States, Wisconsin | |
University of Wisconsin | |
Madison, Wisconsin, United States, 53792 | |
Canada, British Columbia | |
Vancouver Hospital | |
Vancouver, British Columbia, Canada | |
Canada, Ontario | |
University of Western Ontario - St. Joseph's Hospital | |
London, Ontario, Canada |
Principal Investigator: | James E. Lingeman, MD | Methodist Urology |
Responsible Party: | Methodist Urology ( James Lingeman ) |
Study ID Numbers: | 06-035 |
Study First Received: | July 11, 2006 |
Last Updated: | January 12, 2009 |
ClinicalTrials.gov Identifier: | NCT00351351 |
Health Authority: | United States: Institutional Review Board |
Kidney Stones Renal Calculi |
Pathological Conditions, Anatomical Urinary Calculi Urologic Diseases Urolithiasis |
Kidney Diseases Calculi Nephrolithiasis Kidney Calculi |