Vasculaire Compression System Increases Flow Velocity in the Femoral Vein

This study has been completed.
Sponsor:
Information provided by:
Venous Health Systems, Inc.
ClinicalTrials.gov Identifier:
NCT01240330
First received: November 10, 2010
Last updated: March 2, 2011
Last verified: March 2011
  Purpose

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.


Condition Intervention
Venous Thrombosis
Device: Pneumatic Compression therapy

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Evaluation of the Effect of the Vasculaire Compression System on Flow Velocity in the Femoral Vein

Resource links provided by NLM:


Further study details as provided by Venous Health Systems, Inc.:

Primary Outcome Measures:
  • Change in Femoral Venous Peak Flow Velocity Compared to Resting Baseline [ Time Frame: 3 measurements/10 min. therapy ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • PFV Percent Augmentation [ Time Frame: 3 measurements/10 minute therapy ] [ Designated as safety issue: No ]
    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.

  • Subject Comfort [ Time Frame: 10 min therapy ] [ Designated as safety issue: No ]
    Subject comfort was measured on a scale 1 to 5 (1=negative response; 5=positive response) during the sleeve installation, during use, and completion.


Enrollment: 33
Study Start Date: August 2010
Study Completion Date: September 2010
Primary Completion Date: September 2010 (Final data collection date for primary outcome measure)
Intervention Details:
    Device: Pneumatic Compression therapy
    Subject comparison analysis of femoral venous Peak Flow Velocity at rest and during compression therapy.
    Other Names:
    • Intermittent pneumatic compression
    • Sequential compression
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

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01240330

Locations
United States, California
Venous Health System, Inc.
Portola Valley, California, United States, 94028
Sponsors and Collaborators
Venous Health Systems, Inc.
Investigators
Principal Investigator: Thomas J Fogarty, M.D. Founder
  More Information

No publications provided

Responsible Party: Thomas J. Fogarty, M.D. Principal Investigator, Venous Health Systems, Inc.
ClinicalTrials.gov Identifier: NCT01240330     History of Changes
Other Study ID Numbers: VenousHealth-001
Study First Received: November 10, 2010
Results First Received: November 22, 2010
Last Updated: March 2, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by Venous Health Systems, Inc.:
Deep Vein Thrombosis
Effects of compression therapy
Peak Flow Velocity

Additional relevant MeSH terms:
Thrombosis
Venous Thrombosis
Venous Thromboembolism
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases
Thromboembolism

ClinicalTrials.gov processed this record on July 24, 2014