NCT04774939

EVLA and Optimal Timing of Sclerotherapy

FinnTrunk, EVLA and Optimal Timing of Sclerotherapy

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 350 (estimated)
• Sponsor: Turku University Hospital · Other Government
• Sex: All
• Age: 18 Years – 99 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Venous Reflux

Interventions

Type	Name	Description
PROCEDURE	Endovenous laser ablation	The aim is to combine the significance of for sclerotherapy at the primary EVLA treatment

Timeline

• Start date: 2021-03-15
• Primary completion: 2027-03-15
• Completion: 2030-03-15
• First posted: 2021-03-01
• Last updated: 2021-03-01

Locations

1 site across 1 country: Finland