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Polidocanol Microfoam

Phase 2

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

Polidocanol Microfoam target and mechanism

ModalitySmall molecule

Also known as Polidocanol (1%) Microfoam (Varisolve)

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLEDDMC
Total Trials1
Total Enrollment60

FDA Designations

No designations recorded

Polidocanol Microfoam clinical trials

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?

Polidocanol Microfoam is an investigational small molecule therapy being developed for the treatment of varicose veins. It is a foam formulation of polidocanol, also known as polidocanol (1%) microfoam or Varisolve, and is administered as part of a procedure. It is in Phase 2 clinical development.

What is Polidocanol Microfoam used for?

Polidocanol Microfoam is being studied for the treatment of varicose veins, a cardiovascular condition. The clinical program has evaluated its use in patients with varicose veins, including a safety study in patients with a right-to-left cardiac shunt. It is not yet approved and remains investigational.

Who makes Polidocanol Microfoam?

Polidocanol Microfoam is developed by Boston Scientific Corporation, which trades on the New York Stock Exchange under the ticker BSX. The company is the sponsor of the clinical program evaluating the agent for varicose veins.

What phase is Polidocanol Microfoam in?

Polidocanol Microfoam is in Phase 2 clinical development. It is an investigational agent and has not been approved by the FDA for any indication. One Phase 2 trial has been completed, and no trials are currently active.

What clinical trials is Polidocanol Microfoam in?

Polidocanol Microfoam has been evaluated in one completed Phase 2 trial, NCT00442364, titled a safety study of the Varisolve procedure for treatment of varicose veins in patients with right-to-left cardiac shunt. The trial enrolled 60 patients in the United States and has completed.

Is Polidocanol Microfoam the same as Varisolve?

Yes. Polidocanol Microfoam is also known as polidocanol (1%) microfoam, or Varisolve. These names refer to the same investigational product developed by Boston Scientific Corporation for the treatment of varicose veins.