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Sponsors and Collaborators: |
Lawson Health Research Institute Boston Scientific Corporation |
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Information provided by: | Lawson Health Research Institute |
ClinicalTrials.gov Identifier: | NCT00250406 |
The purpose of this study is to determine the clinical effects of a triclosan stent on adherent bacteria, stent biofilms, and patient urine cultures in patients with an indwelling triclosan ureteral stent. The patient populations that will be tested include: patients following ureteroscopy, patients who require chronic long-term stenting, and patients scheduled to undergo shockwave lithotripsy who require a ureteral stent. It is hypothesized that triclosan eluting ureteral stents will reduce the number of bacteria both on (within biofilm) and around (in the urine) a ureteral stent.
Condition | Intervention | Phase |
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Renal Calculi Ureteral Obstruction |
Device: Ureteral Stent |
Phase II |
Study Type: | Interventional |
Study Design: | Prevention, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study |
Official Title: | Assessment of Bacterial Adherence and Biofilm Formation on a Triclosan Loaded Ureteral Stent: A Phase II Study |
Estimated Enrollment: | 30 |
Study Start Date: | November 2005 |
Estimated Study Completion Date: | January 2009 |
Estimated Primary Completion Date: | January 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Active Comparator
Percuflex Plus Ureteral Stent
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Device: Ureteral Stent
Percuflex Plus Stent as the control
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2: Experimental
TRIUMPH stent (triclosan-eluting stent)
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Device: Ureteral Stent
triclosan-eluting ureteral stent
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Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Canada, Ontario | |
Urology, St. Joseph's Hospital | |
London, Ontario, Canada, N6A 4V2 |
Principal Investigator: | John D Denstedt, MD, FRCSC | St. Joseph's Hospital, The University of Western Ontario |
Responsible Party: | Lawson Health Research Institute ( Dr. John Denstedt ) |
Study ID Numbers: | R-05-646 |
Study First Received: | November 4, 2005 |
Last Updated: | January 20, 2009 |
ClinicalTrials.gov Identifier: | NCT00250406 History of Changes |
Health Authority: | Canada: Health Canada |
urolithiasis ureteral stent triclosan drug eluting |
Antimetabolites Pathological Conditions, Anatomical Anti-Infective Agents Urinary Calculi Urolithiasis Antilipemic Agents Ureteral Diseases Calculi |
Anti-Infective Agents, Local Urologic Diseases Hexachlorophene Ureteral Obstruction Kidney Diseases Nephrolithiasis Triclosan Kidney Calculi |
Antimetabolites Pathological Conditions, Anatomical Anti-Infective Agents Urinary Calculi Molecular Mechanisms of Pharmacological Action Urolithiasis Antilipemic Agents Ureteral Diseases Calculi Pharmacologic Actions |
Anti-Infective Agents, Local Urologic Diseases Therapeutic Uses Ureteral Obstruction Kidney Diseases Nephrolithiasis Triclosan Kidney Calculi Fatty Acid Synthesis Inhibitors |