An Open-label, Single-dose Pilot Study to Evaluate Varisolve® (Polidocanol Endovenous Microfoam (PEM)) 0.125% [0.2%] for Varicose Veins
This study has been completed.
Information provided by (Responsible Party):
BTG International Inc. ( BTG Ltd. )
First received: June 24, 2009
Last updated: September 21, 2011
Last verified: September 2011
To determine the effect and safety of Varisolve® 0.125% [0.2%]
Drug: Polidocanol Endovenous Microfoam 0.125%
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
||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
Primary Outcome Measures:
- Physician determined evaluation of PEM and EMA characteristics [ Time Frame: Immediately ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Elimination of reflux through the SFJ. [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
- Complete occlusion of the GSV [ Time Frame: 8 Weeks ] [ Designated as safety issue: No ]
| Study Start Date:
| Study Completion Date:
| Primary Completion Date:
||December 2009 (Final data collection date for primary outcome measure)
Experimental: Varisolve 0.125%
Drug: Polidocanol Endovenous Microfoam 0.125%
Polidocanol Endovenous Microfoam 0.125%, single dose
Other Name: Varisolve 0.125%
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:
- To evaluate PEM and Endovenous Microfoam Ablation(EMA) characteristics of Varisolve® 0.125% [0.2%] as assessed by the treating physician
- 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
|Ages Eligible for Study:
||18 Years to 75 Years
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
- 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
- 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.
- Current alcohol or drug abuse.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00928421
|Bellevue, Washington, United States |
||BTG International Inc.
No publications provided
||BTG International Inc. ( BTG Ltd. )
History of Changes
|Other Study ID Numbers:
|Study First Received:
||June 24, 2009
||September 21, 2011
||United States: Food and Drug Administration
Keywords provided by BTG International Inc.:
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on March 10, 2014