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

NCT00928421 | Completed Phase 2 Results

• 1 other identifier: VAP.VV014
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Varicose Veins

Keywords

Varicose Veins

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

Varisolve 0.125%

EXPERIMENTAL

Drug: Polidocanol Endovenous Microfoam 0.125%

Interventions

Polidocanol Endovenous Microfoam 0.125% DRUG

Polidocanol Endovenous Microfoam 0.125%, single dose

Also known as: Varisolve 0.125%

Varisolve 0.125%

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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.

Sponsors & Collaborators

• Boston Scientific Corporation: lead

Study Sites (1)

Unknown Facility

Bellevue, Washington, United States

Location

MeSH Terms

Conditions

Varicose Veins

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Results Point of Contact

• Title: David Wright MB FRCS
• Organization: BTG International Inc

david.wright@btgplc.com

610-943-3513

Study Officials

• Ellen Evans

  BTG International Inc.

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 24, 2009
• First Posted: June 26, 2009
• Study Start: June 1, 2009
• Primary Completion: December 1, 2009
• Study Completion: January 1, 2010
• Last Updated: May 13, 2021
• Results First Posted: April 2, 2014

Record last verified: 2021-04

Locations

US (1)