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| Name | Class |
|---|---|
| Boston Scientific Corporation | INDUSTRY |
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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 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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Active Comparator | Percuflex Plus Ureteral Stent |
|
| 2 | Experimental | TRIUMPH stent (triclosan-eluting stent) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ureteral Stent | Device | triclosan-eluting ureteral stent |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | at time of intervention |
| Measure | Description | Time Frame |
|---|---|---|
| Secondary objectives to be assessed include the amount of biofilm adherent to each stent and each patient's urine culture. | at time of intervention |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| John D Denstedt, MD, FRCSC | St. Joseph's Hospital, The University of Western Ontario | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Urology, St. Joseph's Hospital | London | Ontario | N6A 4V2 | Canada |
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| ID | Term |
|---|---|
| D007669 | Kidney Calculi |
| D014517 | Ureteral Obstruction |
| D052878 | Urolithiasis |
| ID | Term |
|---|---|
| D053040 | Nephrolithiasis |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
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| ID | Term |
|---|---|
| D015607 | Stents |
| ID | Term |
|---|---|
| D019736 | Prostheses and Implants |
| D004864 | Equipment and Supplies |
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| Ureteral Stent | Device | Percuflex Plus Stent as the control |
|
|
| D005261 |
| Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D014545 | Urinary Calculi |
| D052801 | Male Urogenital Diseases |
| D002137 | Calculi |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D014515 | Ureteral Diseases |