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Ureteral Stent, Ureteral Stent

Phase 2

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

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
RandomizedACTIVE_CONTROLLEDBiomarker
Total Trials1
Total Enrollment20
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00250406Assessment of Drug-eluting Ureteral Stent on Bacterial Adherence and Biofilm FormationPHASE2 COMPLETED 20 — — Nov 1, 2005Mar 1, 2009Dec 20, 20131 Canada
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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 — 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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