Status:
COMPLETED
Narrow Versus Wide Focal Zones for Shock Wave Lithotripsy of Renal Calculi
Lead Sponsor:
Unity Health Toronto
Collaborating Sponsors:
University of Toronto
University of Western Ontario, Canada
Conditions:
Kidney Stones
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
Shockwave lithotripsy (SWL) is a safe, non-invasive treatment for renal calculi. During SWL energy is focused on in order to break kidney stones and this energy can be varied in size from a narrow (or...
Detailed Description
Shock wave lithotripsy (SWL) is a safe and non-invasive treatment for kidney stones. The SWL machine that is currently in use has a unique feature: the focal zone or the energy that the SWL energy is ...
Eligibility Criteria
Inclusion
- Stone must be radiopaque on a KUB (kidney, ureter and bladder) radiograph, and located within the renal collecting system.
- Patients must have had a CT scan within the past 30 days.
- Stones must be solitary, between 5 and 15 mm in maximal diameter.
- Patient must consent to the trial and be willing to return to their respective lithotripsy unit at 2 weeks and 3 months for follow-up.
- Patients must be treated on the Storz Modulith SLX-F2 machine
Exclusion
- More than one renal calculus on the treated side.
- Radiolucent stones (uric acid, indinavir) or cystine stones.
- Stone size \< 5 mm and \> 15 mm.
- Previous surgical intervention on upper tracts within past five years.
- Congenital anatomic anomalies of the kidney, ureters or bladder (such as calyceal diverticulum, horseshoe kidney, etc.)
- Patient currently taking an α-blocker (alfuzosin, terazosin, doxazosin, tamsulosin, prazosin), calcium channel blocker (verapamil, diltiazem, nifedipine, nicardipine, bepridil, mibefradil), or corticosteroids.
- Pregnancy.
- Age \< 18 years.
- Active urinary tract infection.
- Patient exceed weight limit for SWL table (\>500 lbs)
- Previous SWL treatment for this stone.
- Uncorrected coagulopathy
Key Trial Info
Start Date :
January 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2017
Estimated Enrollment :
275 Patients enrolled
Trial Details
Trial ID
NCT01226875
Start Date
January 1 2011
End Date
April 1 2017
Last Update
October 6 2017
Active Locations (3)
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1
Vancouver General Hospital, Jim Pattison Pavilion G floor station 5 GI/GU Lithotripsy suite
Vancouver, British Columbia, Canada, V5Z 1M9
2
St. Joseph's Hospital, University of Western Ontario
London, Ontario, Canada
3
St. Michael's Hospital, University of Toronto, Toronto, Lithotripsy suite, 5th floor Cardinal Carter North Wing
Toronto, Ontario, Canada, M5B 1W8