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

An Open-label, Single-dose Pilot Study to Evaluate the Efficacy and Safety of Varisolve® (Polidocanol Endovenous Microfoam) 0.125% [0.2%] for the Treatment of Symptomatic, Visible Varicose Veins With Saphenofemoral Junction (SFJ) Incompetence

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

Study Overview

• Status: Completed
• Conditions: Varicose Veins
• Intervention / Treatment: Drug: Polidocanol Endovenous Microfoam 0.125%

Detailed Description

In patients with SFJ incompetence due to reflux of the Great Saphenous Vein (GSV) or major accessory veins, with venous disease manifested by both symptoms and visible varicosities: using duplex ultrasonography, to evaluate the efficacy of Varisolve® 0.125% [0.2%] as assessed by the elimination of SFJ reflux and/or occlusion of the treated vein

• Study Type: Interventional
• Enrollment (Actual): 16
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Washington
    • Bellevue, Washington, United States

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Male or female; age of consent to 75 years
2. Baseline VEINES-Sym Questionnaire score less than 75 points
3. Superficial venous disease manifested by both symptoms and visible varicosities
4. Varicose vein clinical classification CEAP 2 through 5
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
6. Ability to comprehend and sign an informed consent document and complete study questionnaires in English

Exclusion Criteria:

1. Incompetence of the small saphenous vein (SSV)
2. Ultrasonographic or other evidence of current or previous deep vein thrombosis, occlusion or incompetence
3. Leg obesity impairing the ability to access the vein to be treated and/or to follow the post-procedural compression recommendations.
4. Peripheral arterial disease in the leg to be treated contraindicating post-procedural compression.
5. Reduced mobility (inability to maintain a brisk walk unaided for a minimum of 5 minutes per hour per day).
6. 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.
7. History of pulmonary embolism or stroke.
8. Major surgery, prolonged hospitalization or pregnancy within 3 months of screening.
9. Current anticoagulation therapy (within 7 days of enrollment).
10. Participation in a clinical study involving an investigational pharmaceutical product or device within the 3 months prior to screening.
11. Previous treatment in this study or in a previous Varisolve® study.
12. 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.
13. Known allergic response to polidocanol, or severe and multiple allergic reactions.
14. 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.
15. Pregnant or lactating women.
16. Current alcohol or drug abuse.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Varisolve 0.125%	Drug: Polidocanol Endovenous Microfoam 0.125%; Polidocanol Endovenous Microfoam 0.125%, single dose; Other Names: Varisolve 0.125%

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Responders to Treatment, Assessed by Duplex Ultrasound	Responders; elimination of reflux through the saphenofemoral junction and/or coplete occlusion of the great saphenous vein at 8 weeks, as measured by duplex ultrasound.	8 weeks

Collaborators and Investigators

• Sponsor: Boston Scientific Corporation
• Investigators: Study Chair: Ellen Evans, BTG International Inc.

Study record dates

Study Major Dates

• Study Start: June 1, 2009
• Primary Completion (ACTUAL): December 1, 2009
• Study Completion (ACTUAL): January 1, 2010

Study Registration Dates

• First Submitted: June 24, 2009
• First Submitted That Met QC Criteria: June 25, 2009
• First Posted (ESTIMATE): June 26, 2009

Study Record Updates

• Last Update Posted (ACTUAL): May 13, 2021
• Last Update Submitted That Met QC Criteria: April 19, 2021
• Last Verified: April 1, 2021

More Information

Terms related to this study

• Keywords: Varicose Veins
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Varicose Veins; Pharmaceutical Solutions; Sclerosing Solutions; Polidocanol
• Other Study ID Numbers: VAP.VV014