Trial Comparing Three Different Devices for Kidney Stone Removal During Percutaneous Surgery
This study is currently recruiting participants.
Verified February 2013 by Indiana Kidney Stone Institute
Sponsor:
Indiana Kidney Stone Institute
Information provided by (Responsible Party):
Indiana Kidney Stone Institute
ClinicalTrials.gov Identifier:
NCT00952315
First received: August 3, 2009
Last updated: February 20, 2013
Last verified: February 2013
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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 2013 |
| Estimated Primary Completion Date: | December 2013 (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
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 | Recruiting |
| Durham, North Carolina, United States, 27710 | |
| Contact: Lori Rawlings, RN 317-962-0870 lrawlings@iuhealth.org | |
| Principal Investigator: Glenn Preminger, MD | |
| 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: | February 20, 2013 |
| 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:
|
Calculi Kidney Calculi Nephrolithiasis Pathological Conditions, Anatomical |
Kidney Diseases Urologic Diseases Urolithiasis Urinary Calculi |
ClinicalTrials.gov processed this record on May 19, 2013