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| Descriptive Information Fields | |||||
| Brief Title † | Assessment of Drug-Eluting Ureteral Stent on Bacterial Adherence and Biofilm Formation | ||||
| Official Title † | Assessment of Bacterial Adherence and Biofilm Formation on a Triclosan Loaded Ureteral Stent: A Phase II Study | ||||
| Brief Summary | 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. |
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| Detailed Description | |||||
| Study Phase | Phase II | ||||
| Study Type † | Interventional | ||||
| Study Design † | Prevention, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study | ||||
| Primary Outcome Measure † | Primary objective is to determine if the number of stent adherent bacteria will be less in patients who receive a triclosan stent compared to a control/standard stent. [ Time Frame: at time of intervention ] [ Designated as safety issue: No ] | ||||
| Secondary Outcome Measure † | Secondary objectives to be assessed include the amount of biofilm adherent to each stent and each patient's urine culture. [ Time Frame: at time of intervention ] [ Designated as safety issue: No ] | ||||
| Condition † | Renal Calculi Ureteral Obstruction |
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| Intervention † | Device: Ureteral Stent | ||||
| MEDLINE PMIDs | |||||
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| Recruitment Information Fields | |||||
| Recruitment Status † | Recruiting | ||||
| Enrollment † | 30 | ||||
| Start Date † | November 2005 | ||||
| Completion Date | December 2008 | ||||
| Eligibility Criteria † | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 18 Years and older | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts †† |
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| Location Countries † | Canada | ||||
| Administrative Information Fields | |||||
| NCT ID † | NCT00250406 | ||||
| Organization ID | R-05-646 | ||||
| Secondary IDs †† | |||||
| Study Sponsor † | Lawson Health Research Institute | ||||
| Collaborators †† | Boston Scientific Corporation | ||||
| Investigators † |
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| Information Provided By | Lawson Health Research Institute | ||||
| Verification Date | August 2008 | ||||
| First Received Date † | November 4, 2005 | ||||
| Last Updated Date | August 14, 2008 | ||||