| November 4, 2005 |
| January 20, 2009 |
| November 2005 |
| January 2009 (final data collection date for 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 ] |
| The 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. |
| Complete list of historical versions of study NCT00250406 on ClinicalTrials.gov Archive Site |
| 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 ] |
| Secondary objectives to be assessed include the amount of biofilm adherent to each stent and each patient’s urine culture. |
| |
| Assessment of Drug-Eluting Ureteral Stent on Bacterial Adherence and Biofilm Formation |
| Assessment of Bacterial Adherence and Biofilm Formation on a Triclosan Loaded Ureteral Stent: A Phase II Study |
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. |
| |
| Phase II |
| Interventional |
| Prevention, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study |
- Renal Calculi
- Ureteral Obstruction
|
| Device: Ureteral Stent |
- Active Comparator: Percuflex Plus Ureteral Stent
- Experimental: TRIUMPH stent (triclosan-eluting stent)
|
| |
| |
| Enrolling by invitation |
| 30 |
| January 2009 |
| January 2009 (final data collection date for primary outcome measure) |
Inclusion Criteria:
- Patients who undergo ureteroscopy for any reason and require a ureteral stent post-operatively as determined by the surgeon (e.g. renal obstruction, ureteral edema, ureteral perforation, large stone fragments to pass, following ureteral dilation, ureteral trauma, solitary kidney, or any other reason left to the discretion of the surgeon).
- Patients undergoing extracorporeal shockwave lithotripsy (ESWL) who will require a stent as determined by the treating urologist (e.g. solitary kidney, ureteral stone > 1 cm, renal stone > 1.5 cm, significant renal obstruction, history of pyelonephritis, or any other reason left to the discretion of the surgeon).
- Patients who have or are going to have chronic ureteral stents, for any reason.
- Patients willing to return to St. Joseph's Hospital's Urology Clinic for follow-up.
Exclusion Criteria:
- Age ≤ 17 years
- Patients unable to consent.
- Any patient requiring endocarditis or prosthetic device prophylaxis (e.g. fresh arthroplasty etc.).
- Pregnant females
- Immunocompromised patients
- Significant urinary symptoms (urgency, dysuria, strangury, hematuria) or other bladder pathology that may cause these symptoms (e.g. interstitial cystitis)
- Anyone in the investigator's opinion that would be unsuitable.
|
| Both |
| 18 Years and older |
| No |
| Contact information is only displayed when the study is recruiting subjects |
| Canada |
| |
| NCT00250406 |
| Dr. John Denstedt, Lawson Health Research Institute |
| R-05-646 |
| Lawson Health Research Institute |
| Boston Scientific Corporation |
| Principal Investigator: |
John D Denstedt, MD, FRCSC |
St. Joseph's Hospital, The University of Western Ontario |
|
|
| Lawson Health Research Institute |
| January 2009 |
