Pharmacokinetic Study of Polidocanol Endovenous Microfoam (PEM)

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 21

Inclusion Criteria

Male or female; age 18 to 75 years
Superficial venous disease where SFJ incompetence is the predominant source of reflux (reflux > 0.5 seconds on duplex ultrasonography) associated with incompetence of the great saphenous vein (GSV) or other major accessory vein
Expected need for microfoam of 10 mL to fill the incompetent GSV and tributaries (minimum trunk vein diameter of 6mm)
Clinically normal renal and hepatic function on serum chemistry
Ability to comprehend and sign an informed consent document in English

Exclusion Criteria

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.)
Clinically significant abnormal ECG or clinical condition which may affect interpretation of ECG, for example, history of Long QT Syndrome, Brugada Syndrome, electronic cardiac pacemaker, chronic atrial fibrillation, recent myocardial infarction or congestive heart failure.
Patients taking QT prolonging medications
Any of the following findings on screening ECG:
QRS > 110 ms
HR < 45 bpm
HR > 100 bpm
QTcF > 470 ms
PR > 220 ms
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 venous reflux unless clinically insignificant in comparison to superficial reflux
Peripheral arterial disease precluding the wearing of post-procedure compression bandaging and stockings
Reduced mobility (unable to walk unaided for 5 minutes per waking hour)
History of deep vein thrombosis, pulmonary embolism or stroke, including evidence of prior DVT on duplex ultrasound
Major surgery, prolonged hospitalization or pregnancy within 3 months of screening
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 for at least one month prior to study enrollment (i.e., treatment) and/or unwilling to continue birth control until Visit 4
Participation in a clinical study involving an investigational pharmaceutical product or device within the 3 months prior to screening
Previous treatment with Polidocanol Endovenous Microfoam (PEM) in a previous PEM study

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
High Dose Polidocanol Endovenous Microfoam	Polidocanol Endovenous Microfoam (PEM)	-
Medium Dose Polidocanol Endovenous Microfoam	Polidocanol Endovenous Microfoam (PEM)	-

Primary Outcome Measures

Name	Time	Method
Weight-adjusted Polidocanol Cmax (Serum)	pharmacokinetics measured- predose, 1, 4, 5, 7, 9, 11, 14, 15, 17, 20, 25, 30 minutes post dose, 1, 2, 3, 4, 5, 6, 8 hours post dose	Cmax measured and adjusted for weight

Secondary Outcome Measures