Transdermal Radiofrequency V ERASER Versus Polidocanol Sclerotherapy for Reticular Veins and Telangiectasias

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

46 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-01-10

Study Completion Date

2025-04-10

Brief Summary

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This study tested V Eraser, Transdermal radiofrequency versus polidocanol sclerotherapy for the treatment of reticular veins and telangiectasia of the legs

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Detailed Description

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Chronic Venous Disease causes symptoms such as pain, edema, and skin manifestations, including telangiectasias and varicose veins. Sclerotherapy with polidocanol is the gold standard treatment; however, technologies such as laser devices and transdermal radiofrequency are also available. The V Eraser, a device that combines transdermal radiofrequency and sclerotherapy, was developed to treat these conditions.

Methods: This was a prospective, randomized, and comparative study comparing V Eraser with sclerotherapy for the treatment of telangiectasias and reticular veins. Forty-one patients were randomized to either V Eraser or polidocanol sclerotherapy and underwent a single treatment session. Efficacy was assessed using the Aberdeen Varicose Vein Questionnaire and vessel clearance analysis in pre- and post-treatment images.

Conditions

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Varicose Veins Leg Telangiectasias

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

2 arm parallel study

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Radiofrequency V Eraser

radiofrequency

Group Type EXPERIMENTAL

Radiofrequency V Eraser

Intervention Type PROCEDURE

standar of care sclerotherapy

Polidocanol sclerotherapy

Standard of care, varicose veins, sclerotherapy

Group Type ACTIVE_COMPARATOR

Radiofrequency V Eraser

Intervention Type PROCEDURE

standar of care sclerotherapy

Interventions

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Radiofrequency V Eraser

standar of care sclerotherapy

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Patients willing to sign informed consent
* Patients from 18 to 80 years old with CVD classified as CEAP clinical classes C1 to C5, but only telangiectasias and reticular veins not connected to larger varicosities

Exclusion Criteria

* Patients with great saphenous or small saphenous vein insufficiency.
* Patients with allergies to polidocanol
* Patients with contraindications to treat varicose veins

Eligible Sex

ALL

Accepts Healthy Volunteers

No