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

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2014 by Indiana Kidney Stone Institute
Sponsor:
Information provided by (Responsible Party):
Indiana Kidney Stone Institute
ClinicalTrials.gov Identifier:
NCT00952315
First received: August 3, 2009
Last updated: June 23, 2014
Last verified: June 2014

August 3, 2009
June 23, 2014
August 2009
December 2014   (final data collection date for primary outcome measure)
Time to removal of a single, targeted kidney stone [ Time Frame: 1 - 3 months ] [ Designated as safety issue: No ]
Time to removal of a single, targeted kidney stone [ Time Frame: 1 year ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00952315 on ClinicalTrials.gov Archive Site
Device complications such as probes clogging or breaking [ Time Frame: 1-3 months ] [ Designated as safety issue: No ]
Device complications such as probes clogging or breaking [ Time Frame: 1 year ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Trial Comparing Three Different Devices for Kidney Stone Removal During Percutaneous Surgery
Randomized Controlled Trial Comparing Three Different Modalities of Newer Lithotrites For Intracorporeal Lithotripsy

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.

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.

Interventional
Not Provided
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Kidney Stones
  • Device: Cyberwand
    Dual probe lithotrite Cyberwand will be used to remove kidney stone. Duration will be timed and documented.
  • Device: Stonebreaker
    Stonebreaker will be used to break up the kidney stone. Duration will be timed and documented.
  • Device: Lithoclast Select
    Lithoclast Select will be used to break up and remove the kidney stone. Duration will be timed and documented
  • Active Comparator: Stonebreaker
    Stonebreaker will be used to break up the kidney stone. Duration will be timed and documented.
    Intervention: Device: Stonebreaker
  • Active Comparator: Lithoclast Select
    Lithoclast Select will be used to breakup and remove kidney stone. Duration will be timed and documented.
    Intervention: Device: Lithoclast Select
  • Active Comparator: Cyberwand
    The dual probe Cyberwand device will be used to fragment and remove the kidney stone. Duration will be timed and documented.
    Intervention: Device: Cyberwand
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
270
December 2014
December 2014   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact: Lori Rawlings, RN 317-962-0870 lrawlings@iuhealth.org
United States,   Canada
 
NCT00952315
09-045
No
Indiana Kidney Stone Institute
Indiana Kidney Stone Institute
Not Provided
Principal Investigator: James E Lingeman, MD IU Health Physicians Urology
Indiana Kidney Stone Institute
June 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP