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Multicentred, Randomized Control Trial Comparing Narrow Versus Wide Focal Zones for Shock Wave Lithotripsy of Renal Calculi

This study is currently Recruiting

February 2011 By University of British Columbia

First Recieved on October 20, 2010

Last Updated on February 8, 2011

Sponsor: University of British Columbia
Collaborators:
Information provided by: University of British Columbia
Identifier: NCT01226875

Purpose

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 small) focal zone to a wide (or large) focal zone. This is a multi-centered, randomized study comparing the single treatment success rates of narrow and wide focal zones during SWL.

Study Type: Interventional
Study Design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Eligibility

Ages Eligible for Study:18 Years
Genders Eligible for Study:Both
Accepts Healthy Volunteers:No
Criteria

Inclusion Criteria: - Stone must be radiopaque on a KUB 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 Criteria: - 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 ?-blocker (alfuzosin, terazosin, doxasosin, 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

Investigators

  • Investigator: John Honey - Principal Investigator - St. Michael's Hospital, University of Toronto
  • Investigator: Ken Pace - Principal Investigator - St. Michael's Hospital, University of Toronto
  • Investigator: Ben H. Chew - Principal Investigator - University of British Columbia - Vancouver Coastal Health Research Institute
  • Investigator: Ryan F. Paterson - Principal Investigator - University of British Columbia - Vancouver Coastal Health Research Institute

Locations

  • Alberta Urology Institute, University of Alberta Hospital

    Edmonton, Alberta Canada

  • Vancouver General Hospital, Jim Pattison Pavilion, G floor, station 5, GI/GU, Lithotripsy suite

    Vancouver, British Columbia V5Z 1M9 Canada

  • St. Joseph's Hospital, University of Western Ontario

    London, Ontario Canada

  • St. Michael's Hospital Stone Centre, 30 Bond St., 5th Fl Rm 031 Cardinal Carter Wing

    Toronto, Ontario M5B 1W8 Canada

  • Royal Victoria Hospital, McGill University

    Montreal, Quebec Canada

Conditions related to this trial:

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