Skip to main content
OpenTrials
Not Yet Recruiting

NCT Number: NCT04774939

EVLA and Optimal Timing of Sclerotherapy

The aim of the study is to investigate the optimal timing of sclerotherapy for treatment of varicose tributaries on EVLA (endogenous laser ablation) patients.

Not Yet Recruiting

Trial opening soon.

Get Notified

Key information

Conditions

Venous Reflux

Age range

18 year–99 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

The study inclusion criteria is patients with main trunk (VSM, SSV, AASV) reflux to be treated with EVLA, suffering C2-C3 varicose disease, age 18-years and no severe co-morbidities.

Patients with written consent will be randomized to two primary treatments groups; EVLA only and EVLA combined with sclerotherapy of varicose tributaries. The primary outcome is the requirement additional sclerotherapy on 3 month control visit. Other study outcomes are pain, quality of life (veins questionnaire), severity score and also recurring of varicose disease at 1, 3 and 5 years.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Varicose disease of lower extremity caused by reflux of VSM, SSV or AASV to be treated with EVLA. Age over 18 years. Clinical symptoms C2-3.

Exclusion criteria

  • No severe comorbidities. Previous DVT.

Treatment and study plan

Endovenous laser ablation

Procedure

The aim is to combine the significance of for sclerotherapy at the primary EVLA treatment

Other names: Endovenous laser ablation combined with foam sclerotherapy of varicose tributaries

Primary outcomes

  1. re-intervention

    Time frame: 3 months

    Requirement of re-intervention

  2. Pain after procedure

    Time frame: up to 3 months after the treatment

    Post procedural pain measured with VAS scale

  3. Quality of life before after procedure

    Time frame: up to 5 years

    Quality of life will be measured with Veins questionnaire

  4. Recur

    Time frame: up to 5 years

    The recurring varicose veins

Secondary outcomes

  1. Surgical complications

    Time frame: 3 months

    Infections, DVT, Pulmonary embolus will be reported

Study contacts

Contact information is provided by the study sponsor or research team.

Harri Hakovirta, Professor

CONTACT

[email protected]

+358405918811

Khalil Firoozi, MD

CONTACT

[email protected]

+35823130000

Sponsors and collaborators

Lead sponsor

Turku University Hospital

Other Gov

Collaborators

  • Helsinki University Central Hospital
  • Oulu University Hospital
  • Päijänne Tavastia Central Hospital
  • Satasairaala
  • Tampere University Hospital
  • Vaasa Central Hospital, Vaasa, Finland

Registry information

Official study title

FinnTrunk, EVLA and Optimal Timing of Sclerotherapy

Acronym: FinnTrunk

Important dates

Study start
2021
Primary completion
2027
Study completion
2030
First posted
Mar 1, 2021
Registry last updated
Mar 1, 2021

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.

Related clinical trials

Published trials that share one or more normalized conditions with this study.