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Polidocanol Endovenous Microfoam (PEM) Versus Vehicle for the Treatment of Saphenofemoral Junction (SFJ) Incompetence
NCT01231373 · View on ClinicalTrials.gov ↗
Study Summary
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.
Conditions Studied
Interventions
- DRUG Vehicle
- DRUG polidocanol injectable foam, 0.125%
- DRUG polidocanol injectable foam, 0.5%
- DRUG polidocanol injectable foam, 1.0%
Study Locations (12)
California
- — San Diego
- — San Diego
Maryland
- — Frederick
- — Hunt Valley
Pennsylvania
- — Monroeville
- — Pittsburgh
Alabama
- — Dothan
Indiana
- — Lafayette
New Mexico
- — Los Alamos
Oklahoma
- — Oklahoma City
South Carolina
- — Greenville
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 235 participants |
| Start Date | 2010-11 |
| Est. Completion | 2014-08 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01231373
The ClinicalTrials.gov registry entry for NCT01231373 describes a study currently listed as completed. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 235 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Boston Scientific Corporation, which has 120 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 1 condition, with Varicose Veins appearing as the primary indexed condition, and to 4 interventions — of which Vehicle is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT01231373 reports 12 study locations spanning 9 distinct geographic areas — top geographies include California, Maryland, Pennsylvania. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT01231373 about?
NCT01231373 is a clinical study titled "Polidocanol Endovenous Microfoam (PEM) Versus Vehicle for the Treatment of Saphenofemoral Junction (SFJ) Incompetence". 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 concentra...
What is the current status of trial NCT01231373?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 235 participants. The study started on 2010-11. Estimated completion is 2014-08.
What conditions does trial NCT01231373 study?
This clinical trial studies the following conditions: Varicose Veins. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT01231373?
The interventions under investigation include: Vehicle (DRUG), polidocanol injectable foam, 0.125% (DRUG), polidocanol injectable foam, 0.5% (DRUG), polidocanol injectable foam, 1.0% (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT01231373?
This trial is sponsored by Boston Scientific Corporation, which has 120 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT01231373 being conducted?
This trial has 12 study locations across Alabama, California, Indiana, Maryland, New Mexico. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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