Status:
COMPLETED
The StoneBreakerTM Trial
Lead Sponsor:
University of British Columbia
Collaborating Sponsors:
VGH and UBC Hospital Foundation
Vancouver Coastal Health
Conditions:
Percutaneous Nephrolithotripsy
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
The purpose of this study is to compare the LMA StoneBreakerTM to the current standard of pneumatic lithotripsy, the Swiss LithoClastR, during percutaneous nephrolithotripsy (PNL).
Detailed Description
Objective: The purpose of this study is to compare the LMA StoneBreakerTM to the current standard of pneumatic lithotripsy, the Swiss LithoClastR, during percutaneous nephrolithotripsy (PNL). Ration...
Eligibility Criteria
Inclusion
- Patients over the age of 18 undergoing PNL
- Previously untreated renal stones
- Patients with 3 or less individual renal calculi, accessible with a rigid nephroscope
- Stones must be at least \>225mm2 area on KUB
- Patient must have a CT scan prior to treatment
Exclusion
- Patients with an active contraindication for PNL (pregnancy, uncorrected coagulopathy, active urinary infection, contrast allergy)
- Partial staghorn calculi
- Complete staghorn calculi
- Stones in calyceal diverticulum
- Cases requiring multiple tracts
Key Trial Info
Start Date :
February 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 1 2010
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT00677196
Start Date
February 1 2008
End Date
September 1 2010
Last Update
September 27 2010
Active Locations (1)
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1
Vancouver General Hospital
Vancouver, British Columbia, Canada, V5Z 1M9