Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00758420 | Randomized, Single Blind, Placebo Controlled, to Evaluate Efficacy and Safety of Polidocanol Injectable Foam for Treatment of Symptomatic, Visible Varicose Veins With SFJ Incompetence | PHASE2 | COMPLETED | 77 | — | — | Oct 1, 2008 | Aug 1, 2009 | Apr 21, 2021 | 5 | United States |
The VVSymQ is a subset of the VEINES-Sym and consists of the 5 symptoms most relevant to patients. The raw score, which can range from 5 to 30, was transformed to a summary VVSymQ score that ranges from 0 (worst possible symptom health) to 100 (best symptom health) using the following formula: VVSymQ: (Transformed Score) = \[(Raw Score) - 5\] \* 4.
| Arm | Type | Description |
|---|---|---|
| 1 | ACTIVE_COMPARATOR | Varisolve (polidocanol endovenous mircofoam) |
| 2 | PLACEBO_COMPARATOR | Agitated saline |
| Name | Type | Description |
|---|---|---|
| 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 Saline | DRUG | 10 u/mL normal heparinized saline solution, up to 20 mL, one treatment session |
Inclusion Criteria: * Males and Females 18-65 years old * VEINES Sym Score less than 75 points * Varicose Vein clinical classification CEAP 2, 3, 4, or 5 * Incompetence of SFJ associated with incompetence of the GSV or other major accessory vein * Superficial venous disease manifested by both sympt...