Polidocanol Endovenous Microfoam (PEM) Versus Vehicle for the Treatment of Saphenofemoral Junction (SFJ) Incompetence
Public ClinicalTrials.gov record NCT01231373. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Randomized, Blinded, Multicenter Study to Evaluate the Efficacy and Safety of Varisolve Polidocanol Endovenous Microfoam (PEM) 0.5% and 1% Compared to Vehicle for the Treatment on Saphenofemoral Junction (SFJ) Incompetence "VANISH-2"
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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 three different concentrations of an investigational drug, Polidocanol Endovenous Microfoam (PEM) compared to vehicle (inactive solution) in treating the symptoms and appearance of varicose veins.
Study identification
- NCT ID
- NCT01231373
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 235 participants
Conditions and interventions
Conditions
Interventions
- polidocanol injectable foam, 0.125% Drug
- polidocanol injectable foam, 0.5% Drug
- polidocanol injectable foam, 1.0% Drug
- Vehicle Drug
Drug
Eligibility (public fields only)
- Age range
- 18 Years to 75 Years
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Oct 31, 2010
- Primary completion
- Aug 31, 2011
- Completion
- Jul 31, 2014
- Last update posted
- Apr 20, 2021
2010 – 2014
United States locations
- U.S. sites
- 12
- U.S. states
- 9
- U.S. cities
- 11
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Not listed | Dothan | Alabama | 36303 | — |
| Not listed | San Diego | California | 92120 | — |
| Not listed | San Diego | California | 92121 | — |
| Not listed | Lafayette | Indiana | 47905 | — |
| Not listed | Frederick | Maryland | 21701 | — |
| Not listed | Hunt Valley | Maryland | 21030 | — |
| Not listed | Los Alamos | New Mexico | 87544 | — |
| Not listed | Oklahoma City | Oklahoma | 73104 | — |
| Not listed | Monroeville | Pennsylvania | 15143 | — |
| Not listed | Pittsburgh | Pennsylvania | 15232 | — |
| Not listed | Greenville | South Carolina | 29615 | — |
| Not listed | Bellevue | Washington | 98004 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT01231373, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Apr 20, 2021 · Synced Sep 7, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT01231373 live on ClinicalTrials.gov.