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

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ClinicalTrials.gov Identifier: NCT00928421
Recruitment Status : Completed
First Posted : June 26, 2009
Results First Posted : April 2, 2014
Last Update Posted : April 2, 2014
Sponsor:
Information provided by (Responsible Party):
BTG International Inc.

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

Condition or disease Intervention/treatment Phase
Varicose Veins Drug: Polidocanol Endovenous Microfoam 0.125% Phase 2

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  (Clinical Trial)
Actual Enrollment : 16 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : June 2009
Actual Primary Completion Date : December 2009
Actual Study Completion Date : January 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Varicose Veins
Drug Information available for: Polidocanol
U.S. FDA Resources

Arm Intervention/treatment
Experimental: Varisolve 0.125% Drug: Polidocanol Endovenous Microfoam 0.125%
Polidocanol Endovenous Microfoam 0.125%, single dose
Other Name: Varisolve 0.125%



Primary Outcome Measures :
  1. Responders to Treatment, Assessed by Duplex Ultrasound [ Time Frame: 8 weeks ]
    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.



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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00928421


Locations
United States, Washington
Bellevue, Washington, United States
Sponsors and Collaborators
BTG International Inc.
Investigators
Study Chair: Ellen Evans BTG International Inc.

Responsible Party: BTG International Inc.
ClinicalTrials.gov Identifier: NCT00928421     History of Changes
Other Study ID Numbers: VAP.VV014
First Posted: June 26, 2009    Key Record Dates
Results First Posted: April 2, 2014
Last Update Posted: April 2, 2014
Last Verified: February 2014

Keywords provided by BTG International Inc.:
Varicose Veins

Additional relevant MeSH terms:
Varicose Veins
Vascular Diseases
Cardiovascular Diseases
Polidocanol
Sclerosing Solutions
Pharmaceutical Solutions