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| Sponsors and Collaborators: |
Lawson Health Research Institute Boston Scientific Corporation |
| Information provided by: | Lawson Health Research Institute |
| ClinicalTrials.gov Identifier: | NCT00250406 |
Purpose
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 |
|
Renal Calculi Ureteral Obstruction |
Device: Ureteral Stent |
Phase II |
| ChemIDplus related topics: | Triclosan Hexachlorophene |
| 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: | December 2008 |
| Estimated Primary Completion Date: | December 2008 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|
1: Active Comparator
Percuflex Plus Ureteral Stent
|
Device: Ureteral Stent
Percuflex Plus Stent as the control
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2: Experimental
TRIUMPH stent (triclosan-eluting stent)
|
Device: Ureteral Stent
triclosan-eluting ureteral stent
|
Eligibility
| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: Linda Nott, Reg N | 519-646-6310 | Linda.Nott@sjhc.london.on.ca |
| Canada, Ontario | |||||
| Urology, St. Joseph's Hospital | Recruiting | ||||
| London, Ontario, Canada, N6A 4V2 | |||||
| Contact: Linda Nott, Reg N 519-646-6310 Linda.Nott@sjhc.london.on.ca | |||||
| Principal Investigator: John D Denstedt, MD, FRCSC | |||||
| Lawson Health Research Institute |
| Boston Scientific Corporation |
| Principal Investigator: | John D Denstedt, MD, FRCSC | St. Joseph's Hospital, The University of Western Ontario |
More Information
| Responsible Party: | Lawson Health Research Institute ( Dr. John Denstedt ) |
| Study ID Numbers: | R-05-646 |
| First Received: | November 4, 2005 |
| Last Updated: | August 14, 2008 |
| ClinicalTrials.gov Identifier: | NCT00250406 |
| Health Authority: | Canada: Health Canada |
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