Vasculaire Compression System Increases Flow Velocity in the Femoral Vein

NCT01240330 | Completed Results

• 1 other identifier: VenousHealth-001
• Study Type: interventional
• Target: 33
• Locations: 1 country
• Sites: 1

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.

Conditions

Venous Thrombosis

Keywords

Deep Vein Thrombosis; Effects of compression therapy; Peak Flow Velocity

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (2)

• PFV Percent Augmentation

  3 measurements/10 minute therapy

• Subject Comfort

  10 min therapy

Interventions

Pneumatic Compression therapy DEVICE

Subject comparison analysis of femoral venous Peak Flow Velocity at rest and during compression therapy.

Also known as: Intermittent pneumatic compression, Sequential compression

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Venous Health Systems, Inc.: lead

Study Sites (1)

Venous Health System, Inc.

Portola Valley, California, 94028, United States

Location

MeSH Terms

Conditions

Venous Thrombosis

Interventions

Intermittent Pneumatic Compression Devices

Condition Hierarchy (Ancestors)

Thrombosis; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Equipment and Supplies

Results Point of Contact

• Title: Director of Quality Assurance & Operations
• Organization: Venous Health Systems, Inc.

rlaguna@venoushealth.com

(650)646-3327

Study Officials

• Thomas J Fogarty, M.D.

  Founder

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: November 10, 2010
• First Posted: November 15, 2010
• Study Start: August 1, 2010
• Primary Completion: September 1, 2010
• Study Completion: September 1, 2010
• Last Updated: March 3, 2011
• Results First Posted: February 21, 2011

Record last verified: 2011-03

Locations

US (1)