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Arterial Sealing

Phase 3

Hemostasis of Arterial Punctures | Unknown | Other |Teleflex Incorporated|Last Updated: Dec 9, 2015

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
RandomizedDouble-BlindUNCONTROLLEDBiomarker
Total Trials1
Total Enrollment270
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00388284Safety and Efficacy Study Comparing Thrombin for Arterial SealingPHASE3 COMPLETED 270Aug 1, 2006Mar 1, 2007Dec 9, 20156 United States
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Study Endpoints
Primary Endpoints
Time to Hemostasis
Incidence rate of device-related major complications
Secondary Endpoints
Time to ambulation
Subject satisfaction
Procedure success
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Study Design & Arms
AllocationRANDOMIZED
MaskingDOUBLE
ModelSINGLE_GROUP
PurposeTREATMENT
Interventions
NameTypeDescription
Arterial SealingDEVICE -
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites6

Inclusion Criteria: * The subject is 18 years of age or older * The subject is undergoing a diagnostic or interventional endovascular procedure via a retrograde femoral arterial access * The subject is willing and able to provide appropriate informed consent * The subject is willing and able to com...

Countries:United States
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