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 Ltd.

ClinicalTrials.gov Identifier:

NCT01197833

First received: September 8, 2010

Last updated: March 7, 2013

Last verified: March 2013

History of Changes

Tracking Information
First Received Date ^ICMJE	September 8, 2010
Last Updated Date	March 7, 2013
Start Date ^ICMJE	September 2010
Primary Completion Date	March 2012 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: September 8, 2010)	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 ]
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT01197833 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE	Not Provided
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	Endovenous Ablation With and Without Polidocanol Endovenous Microfoam Treatment for Patients With Great Saphenous Vein Incompetence and Visible Varicosities
Official Title ^ICMJE	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
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 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.
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	Great Saphenous Vein Incompetence Visible Varicosities
Intervention ^ICMJE	Drug: Polidocanol endovenous microfoam (PEM) Polidocanol endovenous microfoam Drug: vehicle All components except API
Study Arm (s)	Experimental: ETA + Low dose polidocanol endovenous microfoam Intervention: Drug: Polidocanol endovenous microfoam (PEM) Experimental: ETA + Mid dose polidocanol endovenous microfoam Intervention: Drug: Polidocanol endovenous microfoam (PEM) Placebo Comparator: ETA + vehicle 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	105
Completion Date	December 2012
Primary Completion Date	March 2012 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	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
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	NCT01197833
Other Study ID Numbers ^ICMJE	VAP.VV017
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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