An Open-label, Single-dose Pilot Study to Evaluate Varisolve® (Polidocanol Endovenous Microfoam (PEM)) 0.125% [0.2%] for Varicose Veins

Completed · Phase 2

Conditions studied: Varicose Veins

In brief

To determine the effect and safety of Varisolve® 0.125% \[0.2%\]

Key facts

Study ID

NCT00928421

Run by

Boston Scientific Corporation

People needed

16

Starts

2009-06-01

Expected to finish

2010-01-01

Last updated by the study team

2021-05-13

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Male or female; age of consent to 75 years
• Baseline VEINES-Sym Questionnaire score less than 75 points
• Superficial venous disease manifested by both symptoms and visible varicosities
• Varicose vein clinical classification CEAP 2 through 5
• Incompetence of SFJ (reflux > 0.5 seconds on duplex ultrasonography) associated with incompetence of the great saphenous vein (GSV) or other major accessory vein
• Ability to comprehend and sign an informed consent document and complete study questionnaires in English

You may not qualify if…

• Incompetence of the small saphenous vein (SSV)
• Ultrasonographic or other evidence of current or previous deep vein thrombosis, occlusion or incompetence
• Leg obesity impairing the ability to access the vein to be treated and/or to follow the post-procedural compression recommendations.
• Peripheral arterial disease in the leg to be treated contraindicating post-procedural compression.
• Reduced mobility (inability to maintain a brisk walk unaided for a minimum of 5 minutes per hour per day).
• Planned prolonged automobile, bus, or air travel within 4 weeks following treatment, unless the patient can walk for at least 5 consecutive minutes every hour during travel.
• History of pulmonary embolism or stroke.
• Major surgery, prolonged hospitalization or pregnancy within 3 months of screening.
• Current anticoagulation therapy (within 7 days of enrollment).
• Participation in a clinical study involving an investigational pharmaceutical product or device within the 3 months prior to screening.
• Previous treatment in this study or in a previous Varisolve® study.
• 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.) or clinically significant laboratory abnormalities.
• Known allergic response to polidocanol, or severe and multiple allergic reactions.
• Women of childbearing potential not using effective contraception for at least one month prior to study enrollment and/or unwilling to continue birth control until their last study visit.
• Pregnant or lactating women.
• Current alcohol or drug abuse.

Where it is running

• Study site — Bellevue, Washington, United States

Full record on ClinicalTrials.gov

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