Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Boston Scientific Corporation
Age
18–75
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Incompetence of SFJ associated with incompetence of the GSV or other major accessory vein
Ability to comprehend and sign an informed consent document and complete study questionnaires in English
Ability to record symptoms in accordance with the protocol
Symptomatic varicose veins
Visible varicose veins
You may not be if
Patients who only have telangiectatic or reticular veins (Clinical Finding C1, as assessed by CEAP Classification of Venous Disorders).
Leg obesity impairing the ability to access the vein to be treated and/or to apply post-procedure compression bandaging and stockings
Ultrasonographic or other evidence of current or previous deep vein thrombosis or occlusion
Deep vein reflux unless clinically insignificant in comparison to superficial reflux
Peripheral arterial disease precluding the wearing of post-procedure compression bandaging and stockings
Reduced mobility
Major surgery, prolonged hospitalization or pregnancy within 3 months of screening
Major co-existing disease (e.g. malignancy; pulmonary disease; renal or hepatic insufficiency; serious skin disease/condition that may compromise the ability of the patient to comply with the compression protocol, etc.)
Known allergic response to polidocanol or heparin, including history of heparin-induced thrombocytopenia, and/or multiple allergic reactions
Current alcohol or drug abuse
Pregnant or lactating women
Women of childbearing potential not using effective contraception
History of DVT, pulmonary embolism, or stroke
Clareo Health | Polidocanol Endovenous Microfoam (PEM) Versus Vehicle for the Treatment of Saphenofemoral Junction (SFJ) Incompetence
