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Ureteral Stent, Ureteral Stent

Phase 2

Renal Calculi | Unknown | Nephrology |Boston Scientific Corporation|Last Updated: Dec 20, 2013

Success Probability

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Market & Valuation

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Trial Design

RandomizedACTIVE_CONTROLLEDBiomarker
Total Trials1
Total Enrollment20

FDA Designations

No designations recorded

Clinical trial landscape

Ureteral Stent, Ureteral Stent · 1 trial · 2 indications

Phase 2 1
NCT00250406Assessment of Drug-eluting Ureteral Stent on Bacterial Adherence and Biofilm FormationRenal Calculi
COMPLETED20 Analytics
PHASE2COMPLETED
Assessment of Drug-eluting Ureteral Stent on Bacterial Adherence and Biofilm Formation
Renal CalculiUnlock trial analytics

Study Endpoints

Primary Endpoints

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

Secondary Endpoints

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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Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelPARALLEL
PurposePREVENTION

Treatment Arms

ArmTypeDescription
1ACTIVE_COMPARATORPercuflex Plus Ureteral Stent
2EXPERIMENTALTRIUMPH stent (triclosan-eluting stent)

Interventions

NameTypeDescription
Ureteral StentDEVICEtriclosan-eluting ureteral stent
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites1

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 kidn...

Countries:Canada
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Frequently asked questions about Ureteral Stent, Ureteral Stent

What is Ureteral Stent used for in Renal Calculi?

Ureteral Stent is an investigational device being studied for use in patients with renal calculi, or kidney stones. It is designed to be placed in the ureter to help maintain drainage and potentially reduce complications associated with stone disease. The device is currently in Phase 2 clinical development.

Who makes Ureteral Stent?

Ureteral Stent is being developed by Boston Scientific Corporation, a medical device company traded on the New York Stock Exchange under the ticker symbol BSX. The company is conducting clinical research to evaluate the safety and effectiveness of this investigational ureteral stent in patients with renal calculi.

What phase is Ureteral Stent in?

Ureteral Stent is in Phase 2 clinical development. It is an investigational device and has not yet been approved by regulatory authorities. One Phase 2 clinical trial has been completed, and the device remains under study for its intended use in patients with renal calculi.

What clinical trials is Ureteral Stent in?

Ureteral Stent has one completed clinical trial registered under NCT00250406, titled "Assessment of Drug-eluting Ureteral Stent on Bacterial Adherence and Biofilm Formation." This Phase 2 study enrolled 20 participants in Canada and evaluated the device in patients with renal calculi and ureteral obstruction.

Is Ureteral Stent the same as a drug-eluting ureteral stent?

Ureteral Stent is an investigational device that is being evaluated as a drug-eluting ureteral stent. The clinical trial NCT00250406 specifically assesses the drug-eluting properties of the stent, focusing on bacterial adherence and biofilm formation. This indicates the stent is designed to release a drug to potentially reduce infection-related complications.