Efficacy and Safety Study of Varisolve™ Polidocanol Endovenous Microfoam (PEM)for the Treatment of Saphenofemoral Junction (SFJ) Incompetence (VANISH-1)

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

BTG Ltd.

ClinicalTrials.gov Identifier:

NCT01072877

First received: February 19, 2010

Last updated: March 7, 2013

Last verified: March 2013

History of Changes

Tracking Information
First Received Date ^ICMJE	February 19, 2010
Last Updated Date	March 7, 2013
Start Date ^ICMJE	November 2010
Primary Completion Date	April 2012 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: November 1, 2010)	Change in patient-reported symptoms of varicose veins [ Time Frame: Week 8 ] [ Designated as safety issue: No ] The absolute change from Baseline in symptom score.
Original Primary Outcome Measures ^ICMJE (submitted: February 19, 2010)	The absolute change from baseline for the VVSymQ. An analysis of the absolute change from baseline using the patient's daily self-assessment of varicose vein pain will be conducted in support of the symptoms endpoint. [ Time Frame: Week 8 ] [ Designated as safety issue: No ]
Change History	Complete list of historical versions of study NCT01072877 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: November 1, 2010)	Change in appearance as rated by patient and central independent photography review [ Time Frame: 8 weeks ] [ Designated as safety issue: No ] The abolsute change form Baseline in appearance score.
Original Secondary Outcome Measures ^ICMJE	Not Provided
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Efficacy and Safety Study of Varisolve™ Polidocanol Endovenous Microfoam (PEM)for the Treatment of Saphenofemoral Junction (SFJ) Incompetence
Official Title ^ICMJE	A Randomized, Blinded, Multicenter Study to Evaluate the Efficacy and Safety of Varisolve™ Polidocanol Endovenous Microfoam (PEM) 0.5%, 1.0%, or 2.0% Compared to Vehicle for the Treatment of Saphenofemoral Junction (SFJ) Incompetence
Brief Summary	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 three different doses of an investigational drug, Polidocanol Endovenous Microfoam (PEM) compared to vehicle (inactive solution) in treating the symptoms and appearance of varicose veins.
Detailed Description	Not Provided
Study Type ^ICMJE	Interventional
Study Phase	Phase 3
Study Design ^ICMJE	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Outcomes Assessor) Primary Purpose: Treatment
Condition ^ICMJE	Varicose Veins Saphenofemoral Junction (SFJ) Incompetence
Intervention ^ICMJE	Drug: Polidocanol Endovenous Microfoam (PEM) Injection of Polidocanol Endovenous Microfoam Drug: Vehicle vehicle
Study Arm (s)	Experimental: Polidocanol endovenous microfoam ultra low dose Intervention: Drug: Polidocanol Endovenous Microfoam (PEM) Experimental: Polidocanol endovenous microfoam low dose Intervention: Drug: Polidocanol Endovenous Microfoam (PEM) Experimental: Polidocanol endovenous microfoam mid dose Intervention: Drug: Polidocanol Endovenous Microfoam (PEM) Experimental: Polidocanol endovenous microfoam high dose Intervention: Drug: Polidocanol Endovenous Microfoam (PEM) Placebo Comparator: Vehicle Injection of vehicle comparator Intervention: Drug: Vehicle
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE	250
Completion Date	December 2012
Primary Completion Date	April 2012 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	Inclusion Criteria: Incompetence of SFJ Ability to comprehend and sign an informed consent document and complete study questionnaires in English Ability to record symptoms in accordance with the protocol Symptomatic varicose veins Visible varicose veins Exclusion Criteria: 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 postprocedure compression bandaging and stockings Ultrasonographic or other evidence of current or previous deep vein thrombosis or occlusion Peripheral arterial disease precluding the wearing of post-procedure compression bandaging and stockings Reduced mobility 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
Gender	Both
Ages	18 Years to 75 Years
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	United States

Administrative Information
NCT Number ^ICMJE	NCT01072877
Other Study ID Numbers ^ICMJE	VAP.VV015
Has Data Monitoring Committee	Yes
Responsible Party	BTG Ltd.
Study Sponsor ^ICMJE	BTG Ltd.
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	BTG Ltd.
Verification Date	March 2013
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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