Vasculaire Compression System Increases Flow Velocity in the Femoral Vein

Venous Thrombosis Clinical Trial

Official title:

Evaluation of the Effect of the Vasculaire Compression System on Flow Velocity in the Femoral Vein

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01240330
• Other study ID #: VenousHealth-001
• Status: Completed
• Phase: N/A
• First received: November 10, 2010
• Last updated: March 2, 2011
• Start date: August 2010
• Est. completion date: September 2010

Study information

• Verified date: March 2011
• Source: Venous Health Systems, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 33
• Est. completion date: September 2010
• Est. primary completion date: September 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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.

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Thrombosis
• Venous Thrombosis

Intervention

Device:
• Pneumatic Compression therapy
Subject comparison analysis of femoral venous Peak Flow Velocity at rest and during compression therapy.

Locations

Country	Name	City	State
United States	Venous Health System, Inc.	Portola Valley	California

Sponsors (1)

Lead Sponsor	Collaborator
Venous Health Systems, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Femoral Venous Peak Flow Velocity Compared to Resting Baseline	The femoral vein in the mid-thigh area was located and the femoral venous Peak Flow Velocity (PFV)was measured using duplex ultrasound during the compression phase of treatment. PFV is the maximum velocity of blood flow achieved when the foot and calf compression is applied. The PFV was then compared to the subject's own baseline PFV using a paired t-test.	3 measurements/10 min. therapy	No
Secondary	PFV Percent Augmentation	Peak Flow Velocity (PFV) from the compression phase subtracted from the PFV from the decompression phase divided by the PFV from the decompression phase expressed as the percent augmentation.	3 measurements/10 minute therapy	No
Secondary	Subject Comfort	Subject comfort was measured on a scale 1 to 5 (1=negative response; 5=positive response) during the sleeve installation, during use, and completion.	10 min therapy	No