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

NCT ID: NCT00250406

Last Updated: 2013-12-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-11-30

Study Completion Date

2009-03-31

Brief Summary

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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.

Detailed Description

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Conditions

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Renal Calculi Ureteral Obstruction

Keywords

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urolithiasis ureteral stent triclosan drug eluting

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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1

Percuflex Plus Ureteral Stent

Group Type ACTIVE_COMPARATOR

Ureteral Stent

Intervention Type DEVICE

Percuflex Plus Stent as the control

2

TRIUMPH stent (triclosan-eluting stent)

Group Type EXPERIMENTAL

Ureteral Stent

Intervention Type DEVICE

triclosan-eluting ureteral stent

Interventions

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Ureteral Stent

triclosan-eluting ureteral stent

Intervention Type DEVICE

Ureteral Stent

Percuflex Plus Stent as the control

Intervention Type DEVICE

Other Intervention Names

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TRIUMPH STENT Percuflex Plus Stent

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Boston Scientific Corporation

INDUSTRY

Sponsor Role collaborator

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

OTHER

Sponsor Role lead

Responsible Party

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John Denstedt

Chair/Chief, Department of Surgery, Western University

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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John D Denstedt, MD, FRCSC

Role: PRINCIPAL_INVESTIGATOR

St. Joseph's Hospital, The University of Western Ontario

Locations

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Urology, St. Joseph's Hospital

London, Ontario, Canada

Site Status

Countries

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Canada

Other Identifiers

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R-05-646

Identifier Type: -

Identifier Source: org_study_id