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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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Frequently asked questions about Arterial Sealing

What is Arterial Sealing used for?

Arterial Sealing is an investigational therapy being studied for hemostasis of arterial punctures, meaning it is intended to stop bleeding at the site where an artery has been punctured. It is being evaluated in a Phase 3 clinical trial for this purpose.

Who makes Arterial Sealing?

Arterial Sealing is being developed by Teleflex Incorporated, a company traded on the New York Stock Exchange under the ticker symbol TFX. Teleflex is conducting clinical research on this product for achieving hemostasis at arterial puncture sites.

What phase is Arterial Sealing in?

Arterial Sealing is in Phase 3 clinical development. It is an investigational product and has not been approved by regulatory authorities. The Phase 3 trial has been completed, and the product remains under investigation for its safety and efficacy.

What clinical trials is Arterial Sealing in?

Arterial Sealing has one completed Phase 3 clinical trial registered under the identifier NCT00388284. The trial, titled "Safety and Efficacy Study Comparing Thrombin for Arterial Sealing," enrolled 270 participants in the United States and evaluated the product for achieving hemostasis of arterial punctures.

Is Arterial Sealing the same as thrombin?

Arterial Sealing is being studied in comparison with thrombin, but it is not stated to be the same as thrombin. The clinical trial NCT00388284 is designed to compare the safety and efficacy of Arterial Sealing against thrombin for achieving hemostasis of arterial punctures.