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NCT00758420 · ClinicalTrials.gov registry record · Phase 2

Randomized, Single Blind, Placebo Controlled, to Evaluate Efficacy and Safety of Polidocanol Injectable Foam for Treatment of Symptomatic, Visible Varicose Veins With SFJ Incompetence

A Phase 2 study of Varicose Veins, sponsored by Boston Scientific Corporation.

Completed
Registry status
Phase 2
Development phase
77
Enrollment target
5
Study locations

NCT00758420: Completed Phase 2 study of Varicose Veins, sponsored by Boston Scientific Corporation.

NCT00758420 is a Phase 2 study of Varicose Veins that has completed, run by Boston Scientific Corporation. The registered enrollment target is 77 participants, below the 157-participant average among 6 other Varicose Veins trials with a reported enrollment target (51% lower). The trial reports 5 study locations across 4 states. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00758420, a Phase 2 study of Varicose Veins, has completed, sponsored by Boston Scientific Corporation.

COMPLETED
Registry status
Phase 2
Development phase
77 participants
Enrollment target
5
Study locations

Study 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.

Primary Outcome

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.

Conditions Studied

Interventions

  • DRUG Varisolve (Polidocanol Endovenous Microfoam)
  • DRUG Agitated Saline

Study Locations (5)

North Carolina

  • - Charlotte
  • - Winston-Salem

Arizona

  • - Scottsdale

New York

  • - New York

Washington

  • - Bellevue

Trial Details

FieldValue
Enrollment Target 77 participants
Start Date 2008-10
Est. Completion 2009-08
Phase Phase 2
Boston Scientific Corporation

280 total trials

What the finished NCT00758420 record still lists

NCT00758420 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 77 participants, a relatively small participant target, below the 157-participant average among 6 other Varicose Veins trials with a reported enrollment target (51% lower).

The record links to 1 condition, with Varicose Veins appearing as the primary indexed condition, and to 2 interventions - of which Varisolve (Polidocanol Endovenous Microfoam) is the first listed.

NCT00758420 lists 5 locations in 4 states (North Carolina, Arizona, New York).

Frequently Asked Questions

What is clinical trial NCT00758420 about?

NCT00758420 is a clinical study titled "Randomized, Single Blind, Placebo Controlled, to Evaluate Efficacy and Safety of Polidocanol Injectable Foam for Treatment of Symptomatic, Visible Varicose Veins With SFJ Incompetence". 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.

What is the current status of trial NCT00758420?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 77 participants. The study started on 2008-10. Estimated completion is 2009-08.

What conditions does trial NCT00758420 study?

This clinical trial studies the following conditions: Varicose Veins.

What interventions are being tested in trial NCT00758420?

The interventions under investigation include: Varisolve (Polidocanol Endovenous Microfoam) (DRUG), Agitated Saline (DRUG).

Who is sponsoring clinical trial NCT00758420?

This trial is sponsored by Boston Scientific Corporation, which has 280 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT00758420 being conducted?

This trial has 5 study locations across Arizona, New York, North Carolina, Washington. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Source: ClinicalTrials.gov NCT00758420, the US trial registry maintained by the National Library of Medicine. NCT00758420 (small enrollment · multi site footprint · completed) retrieved and formatted by PlainTrial, see methodology.