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OpenTrials
Completed

NCT Number: NCT06962813

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

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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Key information

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hospital São Luiz Gonzaga and Hospital da Irmandade Santa Casa de Misericórdia de São Paulo

São Paulo, 02276-140, Brazil

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Radiofrequency V Eraser

Procedure

standar of care sclerotherapy

Primary outcomes

  1. Photographic analysis

    Time frame: 30 days

    Image analysis of photos was performed on day 30. Using the ImageJ software, two blinded evaluators analyzed the pre- and post-procedure photographs, measuring the vessel lengths in both images

  2. Aberdeen AVVQ questionnaire

    Time frame: 30 days

    The Aberdeen Varicose Vein Questionnaire (AVVQ) was applied on day 30

Sponsors and collaborators

Lead sponsor

Science Valley Research Institute

Other

Registry information

Official study title

Transdermal Radiofrequency (V ERASER) Versus Polidocanol Sclerotherapy for the Treatment of Reticular Veins and Telangiectasias: A Randomized Controlled Trial (TYPER Trial)

Acronym: TYPER

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
May 8, 2025
Registry last updated
May 8, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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