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

Primary Purpose

Kidney Stones

Status
Completed
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Cyberwand
Stonebreaker
Lithoclast Select
Sponsored by
Indiana Kidney Stone Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Kidney Stones focused on measuring kidney stones, intracorporeal lithotriptors, kidney stone removal

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Mayo Clinic Scottsdale
  • Northwestern University
  • IU Health Physicians Urology
  • Johns Hopkins
  • Mayo Clinic Rochester
  • Duke University
  • Vanderbilt University Medical Center
  • University of Wisconsin
  • University of British Columbia
  • The University of Western Ontario

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Active Comparator

Arm Label

Stonebreaker

Lithoclast Select

Cyberwand

Arm Description

Stonebreaker will be used to break up the kidney stone. Duration will be timed and documented.

Lithoclast Select will be used to breakup and remove kidney stone. Duration will be timed and documented.

The dual probe Cyberwand device will be used to fragment and remove the kidney stone. Duration will be timed and documented.

Outcomes

Primary Outcome Measures

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)

Secondary Outcome Measures

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

Full Information

First Posted
August 3, 2009
Last Updated
June 27, 2019
Sponsor
Indiana Kidney Stone Institute
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1. Study Identification

Unique Protocol Identification Number
NCT00952315
Brief Title
Trial Comparing Three Different Devices for Kidney Stone Removal During Percutaneous Surgery
Official Title
Randomized Controlled Trial Comparing Three Different Modalities of Newer Lithotrites For Intracorporeal Lithotripsy
Study Type
Interventional

2. Study Status

Record Verification Date
June 2019
Overall Recruitment Status
Completed
Study Start Date
August 2009 (undefined)
Primary Completion Date
October 2016 (Actual)
Study Completion Date
February 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Indiana Kidney Stone Institute

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Kidney Stones
Keywords
kidney stones, intracorporeal lithotriptors, kidney stone removal

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Masking
Participant
Allocation
Randomized
Enrollment
270 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Stonebreaker
Arm Type
Active Comparator
Arm Description
Stonebreaker will be used to break up the kidney stone. Duration will be timed and documented.
Arm Title
Lithoclast Select
Arm Type
Active Comparator
Arm Description
Lithoclast Select will be used to breakup and remove kidney stone. Duration will be timed and documented.
Arm Title
Cyberwand
Arm Type
Active Comparator
Arm Description
The dual probe Cyberwand device will be used to fragment and remove the kidney stone. Duration will be timed and documented.
Intervention Type
Device
Intervention Name(s)
Cyberwand
Intervention Description
Dual probe lithotrite Cyberwand will be used to remove kidney stone. Duration will be timed and documented.
Intervention Type
Device
Intervention Name(s)
Stonebreaker
Intervention Description
Stonebreaker will be used to break up the kidney stone. Duration will be timed and documented.
Intervention Type
Device
Intervention Name(s)
Lithoclast Select
Intervention Description
Lithoclast Select will be used to break up and remove the kidney stone. Duration will be timed and documented
Primary Outcome Measure Information:
Title
Stone Clearance Time in mm2/Min
Description
Clearance rate was calculated by dividing the surface area of the targeted stone (mm2) by the total clearance time (min)
Time Frame
collected intraoperatively from the time stone breakage begins to end of stone removal with a stone extraction basket
Secondary Outcome Measure Information:
Title
Stone-free After First Procedure
Description
Number of participants deemed stone-free after initial stone-removal surgery
Time Frame
Post-operative Day 1
Title
Secondary Procedure Required
Description
Number of participants who required a secondary kidney stone removal procedure
Time Frame
Within three days of initial procedure
Title
Ureteral Stent Placed
Description
Participants requiring a ureteral stent to be placed after initial stone removal procedure
Time Frame
Intra-operatively
Title
Nephrostomy Tube Placed
Description
Participants requiring a nephrostomy tube to be placed at the end of the initial stone removal procedure
Time Frame
Intra-operatively
Title
Use of Other Device
Description
Number of participants in which another stone breakage device was used in addition to the study-assigned lithotrite
Time Frame
Intra-operatively
Title
EBL>400mL
Description
Number of participants with an estimated blood loss greater than 400mL
Time Frame
Intra-operatively
Title
RBC Transfusion
Description
Number of participants who required a blood transfusion post-operatively
Time Frame
Post-operatively <24 hours
Title
Length of Stay
Description
Number of days participants were in hospital. Operative day is Day 1.
Time Frame
Post-operatively
Title
Post-operative Complications
Description
Number of participants who experienced surgery-related post-op complications
Time Frame
Post-operative Days 2 and 3

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
James E Lingeman, MD
Organizational Affiliation
IU Health Physicians Urology
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mayo Clinic Scottsdale
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85054
Country
United States
Facility Name
Northwestern University
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Facility Name
IU Health Physicians Urology
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202
Country
United States
Facility Name
Johns Hopkins
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21224
Country
United States
Facility Name
Mayo Clinic Rochester
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
Facility Name
Duke University
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States
Facility Name
Vanderbilt University Medical Center
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37232
Country
United States
Facility Name
University of Wisconsin
City
Madison
State/Province
Wisconsin
ZIP/Postal Code
53792
Country
United States
Facility Name
University of British Columbia
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V5Z 1M9
Country
Canada
Facility Name
The University of Western Ontario
City
London
State/Province
Ontario
ZIP/Postal Code
N6A 4V2
Country
Canada

12. IPD Sharing Statement

Plan to Share IPD
No
Links:
URL
http://iksi.org
Description
International Kidney Stone Institute - Click here for more information about kidney stone disease

Learn more about this trial

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

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