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NCT01197833 · ClinicalTrials.gov registry record · Phase 3
Endovenous Ablation With and Without Polidocanol Endovenous Microfoam Treatment for Patients With Great Saphenous Vein Incompetence and Visible Varicosities
A Phase 3 study, sponsored by Boston Scientific Corporation.
- Completed
- Registry status
- Phase 3
- Development phase
- 117
- Enrollment target
NCT01197833: Completed Phase 3 study, sponsored by Boston Scientific Corporation.
NCT01197833 is a Phase 3 study that has completed, run by Boston Scientific Corporation. The registered enrollment target is 117 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (85% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01197833, a Phase 3 study, has completed, sponsored by Boston Scientific Corporation.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 117 participants
- Enrollment target
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 two different doses of an investigational drug, Polidocanol Endovenous Microfoam (PEM) compared to vehicle (inactive solution) when used following an approved heat treatment in subjects with varicose veins.
Primary Outcome
The Independent Photography Review - Visible Varicose Veins (IPR-V3) instrument is a 5-point scale used to assess the appearance of a patient's visible varicose veins. At screening, the site clinician was instructed to review the appearance of the patient's varicose veins in the medial section of each leg (a 'live' assessment), then select an IPR-V3 score (i.e., none=0, mild, moderate, severe or very severe=4) that best represented the appearance of the patient's varicose veins. This assessment
Interventions
- DRUG endovenous ablation+polidocanol injectable microfoam 0.125%
- DRUG Endovenous ablation+polidocanol injectable microfoam 1.0%
- DRUG Endovenous ablation+polidocanol injectable foam 2.0%
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 117 participants |
| Start Date | 2010-09 |
| Est. Completion | 2012-12 |
| Phase | Phase 3 |
What the finished NCT01197833 record still lists
NCT01197833 is an interventional study that assigns participants to a tested intervention. The registered 117 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (85% lower).
The record links to 0 conditions, and to 3 interventions - of which endovenous ablation+polidocanol injectable microfoam 0.125% is the first listed.
NCT01197833 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01197833 about?
NCT01197833 is a clinical study titled "Endovenous Ablation With and Without Polidocanol Endovenous Microfoam Treatment for Patients With Great Saphenous Vein Incompetence and Visible Varicosities". 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 two different doses of an...
What is the current status of trial NCT01197833?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 117 participants. The study started on 2010-09. Estimated completion is 2012-12.
What interventions are being tested in trial NCT01197833?
The interventions under investigation include: endovenous ablation+polidocanol injectable microfoam 0.125% (DRUG), Endovenous ablation+polidocanol injectable microfoam 1.0% (DRUG), Endovenous ablation+polidocanol injectable foam 2.0% (DRUG).
Who is sponsoring clinical trial NCT01197833?
This trial is sponsored by Boston Scientific Corporation, which has 280 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01197833's enrollment target sits among peer trials
117 1642nd of 2000 higher than 358 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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