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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Indiana Kidney Stone Institute
ClinicalTrials.gov Identifier:
NCT00351351
First received: July 11, 2006
Last updated: February 22, 2013
Last verified: February 2013
  Purpose

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
Kidney Stones
Device: Cyberwand
Device: single probe ultrasonic

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Randomized Control Trial Comparing Dual Probe Ultrasonic Lithotripsy to a Single Probe Ultrasonic Lithotripsy

Resource links provided by NLM:


Further study details as provided by Indiana Kidney Stone Institute:

Primary Outcome Measures:
  • Kidney Stone Clearance Rate [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    stone clearance rate calculated in mm^2/min per protocol specification


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
Experimental: A
Cyberwand
Device: Cyberwand
FDA approved - dual probe intracorporeal lithotrite
Active Comparator: B
Currently available lithotripsy technology
Device: single probe ultrasonic
FDA-approved - single probe ultrasonic

Detailed 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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00351351

Locations
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
Sponsors and Collaborators
Indiana Kidney Stone Institute
Investigators
Principal Investigator: James E. Lingeman, MD Methodist Urology
  More Information

Publications:
Responsible Party: Indiana Kidney Stone Institute
ClinicalTrials.gov Identifier: NCT00351351     History of Changes
Other Study ID Numbers: 06-035
Study First Received: July 11, 2006
Results First Received: December 4, 2012
Last Updated: February 22, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Indiana Kidney Stone Institute:
Kidney Stones
Renal Calculi

Additional relevant MeSH terms:
Kidney Calculi
Nephrolithiasis
Kidney Diseases
Urologic Diseases
Urolithiasis
Urinary Calculi
Calculi
Pathological Conditions, Anatomical

ClinicalTrials.gov processed this record on April 17, 2014