Clinical trial NCT01240330: Vasculaire Compression System Increases Flow Velocity in the Femoral Vein
Official title: Evaluation of the Effect of the Vasculaire Compression System on Flow Velocity in the Femoral Vein
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Venous Thrombosis
Keywords: Deep Vein Thrombosis
Effects of compression therapy
Peak Flow Velocity
Lead sponsor: Venous Health Systems, Inc.
Sponsor class: INDUSTRY
First posted: 2010-11-15
Enrollment: 33
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

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-arm, open label, prospective, single-center clinical study.

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 admissions annually in the United States. Intermittent pneumatic compression (IPC), which prevents stasis in the lower limbs, has been shown to be a safe and effective method of prophylaxis of DVT in studies comparing the incidence of DVT and pulmonary embolism with and without IPC. IPC devices decrease venous stasis by augmenting the venous blood flow in the lower extremities. Studies have suggested that an important indicator of the effectiveness of an IPC device in preventing DVT is the peak femoral venous velocity augmentation during the compression phase as compared with the decompression phase of the device.

IPC devices produced in the early 1980s and 1990s were cumbersome, noisy and required external power sources, making them suitable only for non-ambulatory patients. Furthermore, these devices have been associated with poor compliance in trauma patients in a hospital setting, and the poor compliance was associated with a higher rate of DVT.

The aim of this study is to test the hemodynamic performance of a new portable IPC device, the Venous Health Systems' Vasculaire Compression System. This new device is designed to provide patient comfort and convenience of use while providing similar improvement in venous blood flow when compared with existing IPC devices.

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.

Primary outcomes:
measure: Change in Femoral Venous Peak Flow Velocity Compared to Resting Baseline
timeFrame: 3 measurements/10 min. therapy
Secondary outcomes:
measure: PFV Percent Augmentation
timeFrame: 3 measurements/10 minute therapy
measure: Subject Comfort
timeFrame: 10 min therapy
Other outcomes:
Locations:
city: Portola Valley
country: United States
facility: Venous Health System, Inc.
state: California
Study officials:
affiliation: Founder
name: Thomas J Fogarty, M.D.
role: PRINCIPAL_INVESTIGATOR
References: