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
  Purpose

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 Intervention
Kidney Stones
Device: Cyberwand
Device: Stonebreaker
Device: Lithoclast Select

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: Randomized Controlled Trial Comparing Three Different Modalities of Newer Lithotrites For Intracorporeal Lithotripsy

Resource links provided by NLM:


Further study details as provided by Indiana Kidney Stone Institute:

Primary Outcome Measures:
  • Time to removal of a single, targeted kidney stone [ Time Frame: 1 - 3 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Device complications such as probes clogging or breaking [ Time Frame: 1-3 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 270
Study Start Date: August 2009
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00952315

Contacts
Contact: Lori Rawlings, RN 317-962-0870 lrawlings@iuhealth.org

Locations
United States, Arizona
Mayo Clinic Scottsdale Recruiting
Phoenix, Arizona, United States, 85054
Contact: Lori Rawlings, RN    317-962-0870    lrawlings@iuhealth.org   
Principal Investigator: Mitchell Humphreys, MD         
United States, Illinois
Northwestern University Recruiting
Chicago, Illinois, United States, 60611
Contact: Lori Rawlings, RN    317-962-0870    lrawlings@iuhealth.org   
Principal Investigator: Robert Nadler, MD         
United States, Indiana
IU Health Physicians Urology Recruiting
Indianapolis, Indiana, United States, 46202
Contact: Lori Rawlings, RN    317-962-0870    lrawlings@iuhealth.org   
Principal Investigator: James E Lingeman, MD         
United States, Maryland
Johns Hopkins Not yet recruiting
Baltimore, Maryland, United States, 21224
Contact: Lori Rawlings, RN    317-962-0870    lrawlings@iuhealth.org   
Principal Investigator: Brian Matlaga, MD         
United States, Minnesota
Mayo Clinic Rochester Recruiting
Rochester, Minnesota, United States, 55905
Contact: Lori Rawlings, RN    317-962-0870    lrawlings@iuhealth.org   
Principal Investigator: Amy E Krambeck, MD         
United States, North Carolina
Duke University Completed
Durham, North Carolina, United States, 27710
United States, Tennessee
Vanderbilt University Medical Center Recruiting
Nashville, Tennessee, United States, 37232
Contact: Lori Rawlings, RN    317-962-0870    lrawlings@iuhealth.org   
Principal Investigator: Nicole Miller, MD         
United States, Wisconsin
University of Wisconsin Recruiting
Madison, Wisconsin, United States, 53792
Contact: Lori Rawlings, RN    317-962-0870    lrawlings@iuhealth.org   
Principal Investigator: Stephen Nakada, MD         
Canada, British Columbia
University of British Columbia Recruiting
Vancouver, British Columbia, Canada, V5Z 1M9
Contact: Olga Arsovska, BSc    (604) 875-4111 ext 62421    olga.arsovska@ubc.ca   
Principal Investigator: Ben Chew, MD         
Sub-Investigator: Ryan Paterson, MD         
Canada, Ontario
The University of Western Ontario Recruiting
London, Ontario, Canada, N6A 4V2
Contact: Lori Rawlings, RN    317-962-0870    lrawlings@iuhealth.org   
Principal Investigator: Hassan Razvi, MD, FRCSC         
Sub-Investigator: John Denstedt, MD,FRCSC         
Sponsors and Collaborators
Indiana Kidney Stone Institute
Investigators
Principal Investigator: James E Lingeman, MD IU Health Physicians Urology
  More Information

Additional Information:
No publications provided

Responsible Party: Indiana Kidney Stone Institute
ClinicalTrials.gov Identifier: NCT00952315     History of Changes
Other Study ID Numbers: 09-045
Study First Received: August 3, 2009
Last Updated: June 23, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Indiana Kidney Stone Institute:
kidney stones
intracorporeal lithotriptors
kidney stone removal

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

ClinicalTrials.gov processed this record on September 16, 2014