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InterVene BlueLeaf Endovenous Valve Formation System

University of North Carolina at Chapel Hill


Description

The purpose of this study is to look at how safe and effective the BlueLeaf System (BLS) works in creating valve-like structures to help keep blood from pooling in your feet and circulating like it's supposed to.


Keywords:

Feet


Category:

Device

Qualifications

 


Age
18 - 99 years


Gender
Any


Study Population

The study population will include up to 5 patients who are candidates for lower extremity endovascular venous intervention with symptomatic Chronic Venous Insufficiency.


Investigator

William Marston
Distinguished Professor
Surgery - Vascular

For questions, contact:

Zachary Gortler
zachary_gortler@med.unc.edu
(919) 843-1268


Recruitment Period End

March 1, 2020

Location

Primary Location
UNC Endovascular Clinic - Meadowmont
300 Meadowmont Village Cir, Chapel Hill, NC 27517, USA

Study Qualifications

Gender Any

Age Range 18 - 99 years

Participant qualification(s) Diagnosis of Chronic Venous Insufficiency of the legs and have failed at least 6 months of conservative therapy.

Not eligible if: Acute Deep Vein Thrombosis within 1 year, Bleeding disorder that cannot be controlled with medication, heart failure, pregnancy

Number of Visits

    » 12 In person visit(s)

    1 Screening, 1 procedure, 9 clinic follow-up visits

    » 0 Remote visit(s)

Participation Period

5 years

Compensation

Reimbursement of $25 per completed visit

By clicking I am interested, your contact information will be sent to the researcher/study coordinator for this study. The coordinator will respond by email with additional information on how to proceed.