Endovenous Ablation With and Without Polidocanol Endovenous Microfoam Treatment for Patients With Great Saphenous Vein Incompetence and Visible Varicosities (017)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
BTG International Inc. ( BTG Ltd. )
ClinicalTrials.gov Identifier:
NCT01197833
First received: September 8, 2010
Last updated: December 9, 2013
Last verified: December 2013

September 8, 2010
December 9, 2013
September 2010
March 2012   (final data collection date for primary outcome measure)
Absolute change from baseline in appearance of visible varicose veins as assessed by Independent Photography Review (IPR)and patient self assessment [ Time Frame: 8 weeks post treatment ] [ Designated as safety issue: No ]
  • Absolute change from baseline in appearance of visible varicose veins as assessed by Independent Photography Review (IPR) [ Time Frame: 8 weeks post treatment ] [ Designated as safety issue: No ]
  • The absolute change from baseline in the appearance of varicose veins by patient self-assessment [ Time Frame: 8 weeks post-treatment ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01197833 on ClinicalTrials.gov Archive Site
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Endovenous Ablation With and Without Polidocanol Endovenous Microfoam Treatment for Patients With Great Saphenous Vein Incompetence and Visible Varicosities
A Multicenter, Randomized, Blinded Study of Endovenous Thermal Ablation With or Without Varisolve™ Polidocanol Endovenous Microfoam (PEM) Treatment for Patients With Great Saphenous Vein Incompetence and Visible Varicosities

Varicose veins are enlarged, noticeably bulging veins, which commonly occur in the legs and may cause discomfort. In this study, patients with varicose veins in the legs will be participating. The purpose of this research study is to evaluate the safety and effectiveness of two different doses of an investigational drug, Polidocanol Endovenous Microfoam (PEM) compared to vehicle (inactive solution) when used following an approved heat treatment in subjects with varicose veins.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Treatment
  • Great Saphenous Vein Incompetence
  • Visible Varicosities
  • Drug: polidocanol injectable microfoam 0.125%
    All components except API
    Other Name: polidocanol endovenous microfoam
  • Drug: polidocanol injectable microfoam 1.0%, endovenous ablation
  • Drug: vehicle (no polidocanol), endovenous ablation
  • Experimental: Endovenous ablation, polidocanol injectable microfoam 0.125%
    Endovenous ablation, polidocanol injectable microfoam 0.125%
    Intervention: Drug: polidocanol injectable microfoam 0.125%
  • Experimental: Endovenous ablation, polidocanol injectable micrfoam, 1.0%
    Endovenous ablation, polidocanol injectable microfoam, 1.0%
    Intervention: Drug: polidocanol injectable microfoam 1.0%, endovenous ablation
  • Active Comparator: endovenous ablation, vehicle
    endovenous ablation, vehicle
    Intervention: Drug: vehicle (no polidocanol), endovenous ablation
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
105
December 2012
March 2012   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Incompetence of SFJ
  • Patients who are candidates for ETA [laser or radiofrequency ablation (RFA)]
  • Symptomatic varicose veins
  • Visible varicose veins
  • Ability to comprehend and sign an informed consent and complete study questionnaires in English

Exclusion Criteria:

  • Patients who only have telangiectatic or reticular veins (Clinical Finding C1, as assessed by CEAP Classification of Venous Disorders)
  • Patients who have active ulceration on the leg to be treated (Clinical Finding C6, 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
  • 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
  • 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.)
  • 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
Both
18 Years to 75 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01197833
VAP.VV017
Yes
BTG International Inc. ( BTG Ltd. )
BTG Ltd.
Not Provided
Not Provided
BTG International Inc.
December 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP