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.

Study Overview

• Status: Completed
• Conditions: Kidney Stones
• Intervention / Treatment: Device: Stonebreaker; Device: Lithoclast Select; Device: Cyberwand

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 Type: Interventional
• Enrollment (Actual): 270
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • British Columbia
    • Vancouver, British Columbia, Canada, V5Z 1M9
      • University of British Columbia
  • Ontario
    • London, Ontario, Canada, N6A 4V2
      • The University of Western Ontario
• United States
  • Arizona
    • Phoenix, Arizona, United States, 85054
      • Mayo Clinic Scottsdale
  • Illinois
    • Chicago, Illinois, United States, 60611
      • Northwestern University
  • Indiana
    • Indianapolis, Indiana, United States, 46202
      • IU Health Physicians Urology
  • Maryland
    • Baltimore, Maryland, United States, 21224
      • Johns Hopkins
  • Minnesota
    • Rochester, Minnesota, United States, 55905
      • Mayo Clinic Rochester
  • North Carolina
    • Durham, North Carolina, United States, 27710
      • Duke University
  • Tennessee
    • Nashville, Tennessee, United States, 37232
      • Vanderbilt University Medical Center
  • Wisconsin
    • Madison, Wisconsin, United States, 53792
      • University of Wisconsin

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Factorial Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Stone-free After First Procedure	Number of participants deemed stone-free after initial stone-removal surgery	Post-operative Day 1
Secondary Procedure Required	Number of participants who required a secondary kidney stone removal procedure	Within three days of initial procedure
Ureteral Stent Placed	Participants requiring a ureteral stent to be placed after initial stone removal procedure	Intra-operatively
Nephrostomy Tube Placed	Participants requiring a nephrostomy tube to be placed at the end of the initial stone removal procedure	Intra-operatively
Use of Other Device	Number of participants in which another stone breakage device was used in addition to the study-assigned lithotrite	Intra-operatively
EBL>400mL	Number of participants with an estimated blood loss greater than 400mL	Intra-operatively
RBC Transfusion	Number of participants who required a blood transfusion post-operatively	Post-operatively <24 hours
Length of Stay	Number of days participants were in hospital. Operative day is Day 1.	Post-operatively
Post-operative Complications	Number of participants who experienced surgery-related post-op complications	Post-operative Days 2 and 3

Collaborators and Investigators

• Sponsor: Indiana Kidney Stone Institute
• Investigators: Principal Investigator: James E Lingeman, MD, IU Health Physicians Urology

Publications and helpful links

Helpful Links

• International Kidney Stone Institute - Click here for more information about kidney stone disease

Study record dates

Study Major Dates

• Study Start: August 1, 2009
• Primary Completion (Actual): October 1, 2016
• Study Completion (Actual): February 1, 2017

Study Registration Dates

• First Submitted: August 3, 2009
• First Submitted That Met QC Criteria: August 4, 2009
• First Posted (Estimate): August 6, 2009

Study Record Updates

• Last Update Posted (Actual): July 5, 2019
• Last Update Submitted That Met QC Criteria: June 27, 2019
• Last Verified: June 1, 2019

More Information

Terms related to this study

• Keywords: kidney stones; intracorporeal lithotriptors; kidney stone removal
• Additional Relevant MeSH Terms: Kidney Diseases; Urologic Diseases; Pathological Conditions, Anatomical; Urolithiasis; Urinary Calculi; Calculi; Kidney Calculi; Nephrolithiasis
• Other Study ID Numbers: 09-045

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No