NCT00928421

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

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 16 (actual)
• Sponsor: Boston Scientific Corporation · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

To determine the effect and safety of Varisolve® 0.125% \[0.2%\]

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

Conditions

• Varicose Veins

Interventions

Type	Name	Description
DRUG	Polidocanol Endovenous Microfoam 0.125%	Polidocanol Endovenous Microfoam 0.125%, single dose

Timeline

• Start date: 2009-06-01
• Primary completion: 2009-12-01
• Completion: 2010-01-01
• First posted: 2009-06-26
• Last updated: 2021-05-13
• Results posted: 2014-04-02

Locations

1 site across 1 country: United States