NCT00250406

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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 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.

Conditions

• Renal Calculi
• Ureteral Obstruction

Interventions

Type	Name	Description
DEVICE	Ureteral Stent	triclosan-eluting ureteral stent
DEVICE	Ureteral Stent	Percuflex Plus Stent as the control

Timeline

• Start date: 2005-11-01
• Primary completion: 2009-03-01
• Completion: 2009-03-01
• First posted: 2005-11-08
• Last updated: 2013-12-20

Locations

1 site across 1 country: Canada