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

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ClinicalTrials.gov Identifier: NCT00952315
Recruitment Status : Completed
First Posted : August 6, 2009
Results First Posted : July 5, 2019
Last Update Posted : July 5, 2019
Sponsor:
Information provided by (Responsible Party):
James Lingeman, Indiana Kidney Stone Institute

Study Description
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Brief 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.

Condition or disease Intervention/treatment Phase
Kidney Stones Device: Cyberwand Device: Stonebreaker Device: Lithoclast Select Not Applicable

Detailed 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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 270 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Randomized Controlled Trial Comparing Three Different Modalities of Newer Lithotrites For Intracorporeal Lithotripsy
Study Start Date : August 2009
Actual Primary Completion Date : October 2016
Actual Study Completion Date : February 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Kidney Stones

Arms and Interventions
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Arm Intervention/treatment
Active Comparator: Stonebreaker
Stonebreaker will be used to break up the 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.
Active Comparator: Lithoclast Select
Lithoclast Select will be used to breakup and remove 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: Cyberwand
The dual probe Cyberwand device will be used to fragment and remove the kidney stone. Duration will be timed and documented.
 Device: Cyberwand
Dual probe lithotrite Cyberwand will be used to remove kidney stone. Duration will be timed and documented.


Outcome Measures
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Primary Outcome Measures :
  1. Stone Clearance Time in mm2/Min [ Time Frame: collected intraoperatively from the time stone breakage begins to end of stone removal with a stone extraction basket ]
    Clearance rate was calculated by dividing the surface area of the targeted stone (mm2) by the total clearance time (min)


Secondary Outcome Measures :
  1. Stone-free After First Procedure [ Time Frame: Post-operative Day 1 ]
    Number of participants deemed stone-free after initial stone-removal surgery

  2. Secondary Procedure Required [ Time Frame: Within three days of initial procedure ]
    Number of participants who required a secondary kidney stone removal procedure

  3. Ureteral Stent Placed [ Time Frame: Intra-operatively ]
    Participants requiring a ureteral stent to be placed after initial stone removal procedure

  4. Nephrostomy Tube Placed [ Time Frame: Intra-operatively ]
    Participants requiring a nephrostomy tube to be placed at the end of the initial stone removal procedure

  5. Use of Other Device [ Time Frame: Intra-operatively ]
    Number of participants in which another stone breakage device was used in addition to the study-assigned lithotrite

  6. EBL>400mL [ Time Frame: Intra-operatively ]
    Number of participants with an estimated blood loss greater than 400mL

  7. RBC Transfusion [ Time Frame: Post-operatively <24 hours ]
    Number of participants who required a blood transfusion post-operatively

  8. Length of Stay [ Time Frame: Post-operatively ]
    Number of days participants were in hospital. Operative day is Day 1.

  9. Post-operative Complications [ Time Frame: Post-operative Days 2 and 3 ]
    Number of participants who experienced surgery-related post-op complications


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00952315


Locations
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United States, Arizona
Mayo Clinic Scottsdale
Phoenix, Arizona, United States, 85054
United States, Illinois
Northwestern University
Chicago, Illinois, United States, 60611
United States, Indiana
IU Health Physicians Urology
Indianapolis, Indiana, United States, 46202
United States, Maryland
Johns Hopkins
Baltimore, Maryland, United States, 21224
United States, Minnesota
Mayo Clinic Rochester
Rochester, Minnesota, United States, 55905
United States, North Carolina
Duke University
Durham, North Carolina, United States, 27710
United States, Tennessee
Vanderbilt University Medical Center
Nashville, Tennessee, United States, 37232
United States, Wisconsin
University of Wisconsin
Madison, Wisconsin, United States, 53792
Canada, British Columbia
University of British Columbia
Vancouver, British Columbia, Canada, V5Z 1M9
Canada, Ontario
The University of Western Ontario
London, Ontario, Canada, N6A 4V2
Sponsors and Collaborators
Indiana Kidney Stone Institute
Investigators
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Principal Investigator: James E Lingeman, MD IU Health Physicians Urology
More Information
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Additional Information:

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Responsible Party: James Lingeman, James Lingeman, MD, Indiana Kidney Stone Institute
ClinicalTrials.gov Identifier: NCT00952315    
Other Study ID Numbers: 09-045
First Posted: August 6, 2009    Key Record Dates
Results First Posted: July 5, 2019
Last Update Posted: July 5, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by James Lingeman, Indiana Kidney Stone Institute:
kidney stones
intracorporeal lithotriptors
kidney stone removal
Additional relevant MeSH terms:
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Kidney Calculi
Nephrolithiasis
Calculi
Pathological Conditions, Anatomical
 Kidney Diseases
Urologic Diseases
Urolithiasis
Urinary Calculi