Status:
COMPLETED
Patient Comfort With Vascular Closure
Lead Sponsor:
University of Florida
Collaborating Sponsors:
Access Pharmaceuticals, Inc.
Conditions:
Vascular Closure
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
The purpose of this research study is to collect information on the amount of discomfort patients experience with one of two different vascular blood vessel closure devices, the MynxM5 Vascular Closur...
Detailed Description
The traditional, standard technique of achieving femoral artery hemostasis following diagnostic and interventional catheterization procedures requires compression methods such as manual pressure or cl...
Eligibility Criteria
Inclusion
- Patient is \>18 years of age
- Patient has been informed and understands the nature of the study and provides written Informed Consent approved by the appropriate Institutional Review Board prior to enrollment
- Patient has been trained and understands the use of the 0-10 Visual Analogue Scale as an assessment of patient pain
- Patient is scheduled to undergo a diagnostic endovascular procedure involving percutaneous access through the common femoral artery
Exclusion
- Per Mynx and Angio-Seal Instructions for Use
- Patient has a documented psychiatric disorder (e.g. major depression, anxiety)
- Patient has a documented chronic pain condition requiring daily treatment
- Patient carries the diagnoses of a known bleeding disorder
- Intraprocedural
Key Trial Info
Start Date :
October 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2010
Estimated Enrollment :
64 Patients enrolled
Trial Details
Trial ID
NCT00998023
Start Date
October 1 2009
End Date
August 1 2010
Last Update
December 6 2011
Active Locations (1)
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1
University of Florida
Gainesville, Florida, United States, 32610