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Polidocanol Microfoam

Phase 2

Varicose Veins | Small molecule | Cardiovascular |Boston Scientific Corporation|Last Updated: Apr 21, 2021

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLEDDMC
Total Trials1
Total Enrollment60

FDA Designations

No designations recorded

Clinical trial landscape

Polidocanol Microfoam · 1 trial · 1 indication

Phase 2 1
NCT00442364Safety Study of Varisolve® Procedure for Treatment of Varicose Veins in Patients With Right-to-left Cardiac ShuntVaricose Veins
COMPLETED60 Analytics
PHASE2COMPLETED
Safety Study of Varisolve® Procedure for Treatment of Varicose Veins in Patients With Right-to-left Cardiac Shunt
Varicose VeinsUnlock trial analytics

Study Endpoints

Primary Endpoints

Patients With Circulating MCA Bubbles Present on MRI Who Had Signficant Clinical or Neurological Effects
28 day followup
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Study Design & Arms

AllocationNON_RANDOMIZED
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
1EXPERIMENTALPolidocanol (1%) Microfoam (Varisolve)

Interventions

NameTypeDescription
Polidocanol (1%) Microfoam (Varisolve)DRUGVarisolve polidocanol 1% microfoam, maximum of 20ml injected into affected great saphenous vein.
Endovenous Microfoam OcclusionPROCEDUREVarisolve® polidocanol microfoam injection under duplex guidance to fill proximal and distal great saphenous vein and varicose tributaries.
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Eligibility Criteria

Age Range18 Years to 60 Years
SexALL
Healthy VolunteersNo
Study Sites7

Inclusion Criteria: * Males and females aged 18 to 60 with severe varicose veins, CEAP classes 3, 4 and 5 (CEAP is a classification and grading system for chronic venous disease) * Saphenofemoral junction (SFJ) incompetence. Retrograde blood flow in the GSV, greater than or equal to 1.0 second demo...

Countries:United States
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Frequently asked questions about Polidocanol Microfoam

What is Polidocanol Microfoam used for?

Polidocanol Microfoam is used for the treatment of varicose veins. It is a small molecule being developed by Boston Scientific Corporation (BSX) for this cardiovascular condition. The drug is currently in Phase 2 clinical development and is considered investigational, meaning it has not yet been approved by regulatory authorities.

Who makes Polidocanol Microfoam?

Polidocanol Microfoam is being developed by Boston Scientific Corporation, a company traded on the New York Stock Exchange under the ticker symbol BSX. The company is conducting clinical trials to evaluate the safety and efficacy of this investigational drug for the treatment of varicose veins.

What phase is Polidocanol Microfoam in?

Polidocanol Microfoam is in Phase 2 clinical development. It is an investigational drug being studied for the treatment of varicose veins. As of the available data, it has not received regulatory approval and remains in clinical testing.

What clinical trials is Polidocanol Microfoam in?

Polidocanol Microfoam has been studied in one completed Phase 2 clinical trial with the identifier NCT00442364. This trial, titled 'Safety Study of Varisolve® Procedure for Treatment of Varicose Veins in Patients With Right-to-left Cardiac Shunt,' enrolled 60 participants in the United States. The study was uncontrolled and did not use randomization or blinding.

Is Polidocanol Microfoam the same as Varisolve?

Polidocanol Microfoam is associated with the brand name Varisolve, as indicated by the clinical trial title 'Safety Study of Varisolve® Procedure for Treatment of Varicose Veins.' The investigational drug is being developed by Boston Scientific Corporation for the treatment of varicose veins.