N/A
N=33
Vasculaire Compression System Increases Flow Velocity in the Femoral Vein
Venous Thrombosis
Bottom Line
View on ClinicalTrials.gov: NCT01240330 ↗Enrolled (actual)
33
Serious AEs
0.0%
Results posted
Feb 2011
Primary outcome: Primary: Change in Femoral Venous Peak Flow Velocity Compared to Resting Baseline — 18.9 cm/s — p=<0.0001
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Pneumatic Compression therapy (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Venous Health Systems, Inc.
- Primary completion
- Sep 2010
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Femoral Venous Peak Flow Velocity Compared to Resting Baseline |
18.9 | <0.0001 sig |
| SECONDARY PFV Percent Augmentation |
175.5 | — |
| SECONDARY Subject Comfort |
4.94; 4.94; 5.00 | — |
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-arm, open label, prospective, single-center clinical study.
Eligibility Criteria
Inclusion Criteria
- 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 Criteria
- 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.
Data sourced from ClinicalTrials.gov (NCT01240330). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.