EVLA and Optimal Timing of Sclerotherapy

FinnTrunk, EVLA and Optimal Timing of Sclerotherapy

Status

Not yet recruiting

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04774939

Acronym

FinnTrunk

Enrollment

350

Registered

2021-03-01

Start date

2021-03-15

Completion date

2030-03-15

Last updated

2021-03-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Venous Reflux

Brief summary

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

Detailed description

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.

Interventions

PROCEDUREEndovenous laser ablation

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to 99 Years

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
re-intervention	3 months	Requirement of re-intervention
Pain after procedure	up to 3 months after the treatment	Post procedural pain measured with VAS scale
Quality of life before after procedure	up to 5 years	Quality of life will be measured with Veins questionnaire
Recur	up to 5 years	The recurring varicose veins

Secondary

Measure	Time frame	Description
Surgical complications	3 months	Infections, DVT, Pulmonary embolus will be reported

Countries

Finland

Contacts

Primary ContactHarri Hakovirta, Professor

haheha@utu.fi+358405918811

Backup ContactKhalil Firoozi, MD

khalil.firoozi@tyks.fi+35823130000

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 9, 2026