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Arterial Sealing

Phase 3

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

Success Probability
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Market & Valuation
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Trial Design
RandomizedDouble-BlindUNCONTROLLEDBiomarker
Total Trials1
Total Enrollment270
FDA Designations
No designations recorded
Clinical trial landscape

Arterial Sealing · 1 trial · 1 indication

Phase 3 1
NCT00388284Safety and Efficacy Study Comparing Thrombin for Arterial SealingHemostasis of Arterial Punctures
COMPLETED270 Analytics
PHASE3COMPLETED
Safety and Efficacy Study Comparing Thrombin for Arterial Sealing
Hemostasis of Arterial PuncturesUnlock trial analytics
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 to 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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