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Assessment of Drug-eluting Ureteral Stent on Bacterial Adherence and Biofilm Formation

NCT00250406 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2013-12-20

No results posted yet for this study

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

DEVICE

Ureteral Stent

triclosan-eluting ureteral stent

DEVICE

Ureteral Stent

Percuflex Plus Stent as the control

Sponsors & Collaborators

  • Boston Scientific Corporation

    collaborator INDUSTRY

  • London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's

    lead OTHER

Principal Investigators

  • John D Denstedt, MD, FRCSC · St. Joseph's Hospital, The University of Western Ontario

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2005-11-30
Primary Completion
2009-03-31
Completion
2009-03-31

Countries

  • Canada

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00250406 on ClinicalTrials.gov