Status:
COMPLETED
Vasculaire Compression System Increases Flow Velocity in the Femoral Vein
Lead Sponsor:
Venous Health Systems, Inc.
Conditions:
Venous Thrombosis
Eligibility:
All Genders
18-65 years
Phase:
NA
Brief Summary
The objective of this clinical study was to demonstrate the performance of the Vasculaire Compression System to increase femoral venous peak velocity (PFV) in healthy subjects. This study was a single...
Detailed Description
Venous thromboembolism, e.g. deep vein thrombosis (DVT) and pulmonary embolism, occurs in approximately one in 1,000 persons in the United States annually and results in more than 250,000 hospital adm...
Eligibility Criteria
Inclusion
- Male or female subjects between 18 years old and 65 years old;
- Capable of and willing to lay supine for approximately one hour;
- Subjects must provide written informed consent
Exclusion
- History of Deep Vein Thrombosis (DVT) or suspected DVT;
- History of vascular disease, e.g. coronary or peripheral artery disease;
- History of stroke;
- History of pulmonary edema;
- History of congestive heart failure;
- Diabetes mellitus;
- Past or present smoker;
- Surgery or trauma to the right leg within the last six months;
- Open ulcers or wounds on the right leg;
- Pregnant or breastfeeding.
Key Trial Info
Start Date :
August 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2010
Estimated Enrollment :
33 Patients enrolled
Trial Details
Trial ID
NCT01240330
Start Date
August 1 2010
End Date
September 1 2010
Last Update
March 3 2011
Active Locations (1)
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1
Venous Health System, Inc.
Portola Valley, California, United States, 94028