At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 77 enrolled
Drug / intervention
Varisolve (Polidocanol Endovenous Microfoam) +1 moredrug
Likely dose
Varisolve (Polidocanol Endovenous Microfoam) 15 mLfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Randomized, Single Blind, Placebo Controlled, Multicenter Study to Evaluate Efficacy and Safety of Polidocanol Injectable Foam for the Treatment of Symptomatic, Visible Varicose Veins With Saphenofemoral Junction (SFJ) Incompetence.
In Brief
A Phase 3 clinical trial evaluating Varisolve (Polidocanol Endovenous Microfoam) and Agitated Saline for Varicose Veins. Completed, enrolled 77 participants across 5 sites.
Detailed Summary
The purpose of this study is to evaluate the effectiveness of polidocanol injectable foam in the relief of symptoms, improvement of appearance, and overall effectiveness and safety in the treatment of varicose veins compared to placebo.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsVaricose Veins
CountriesUnited States
Collaborators--
Timeline
Phase 3CompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
First PostedSep 2008
Enrollment StartOct 2008
Primary CompletionJul 2009
Study CompletionAug 2009
TodayJul 2026
First PostedSep 25, 2008
Enrollment StartOct 1, 2008
Primary CompletionJul 1, 2009
Study CompletionAug 1, 2009
TodayJul 2, 2026
Enrollment to primary: 9 monthsPosted 17.8 years ago
Interventions
Varisolve (Polidocanol Endovenous Microfoam)drug
1% polidocanol, up to 15 mL, one treatment session (initially up to 30 ml, reduced to up to 15 ml in Amendment #2)
Agitated Salinedrug
10 u/mL normal heparinized saline solution, up to 20 mL, one treatment session