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NCT04774939 Clinical Trial

EVLA and Optimal Timing of Sclerotherapy

Venous Reflux Clinical Trial

— FinnTrunk  

Official title:
FinnTrunk, EVLA and Optimal Timing of Sclerotherapy

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT04774939
Other study ID # 93 /1801/2020
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date March 15, 2021
Est. completion date March 15, 2030

Study information
Verified date February 2021
Source Turku University Hospital
Contact Harri Hakovirta, Professor
Phone +358405918811
Email haheha@utu.fi
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Not yet recruiting
Enrollment 350
Est. completion date March 15, 2030
Est. primary completion date March 15, 2027
Accepts healthy volunteers No
Gender All
Age group 18 Years to 99 Years
Eligibility 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.

Study Design

Related Conditions & MeSH terms

Intervention

Procedure:
• Endovenous laser ablation
The aim is to combine the significance of for sclerotherapy at the primary EVLA treatment

Locations
Country Name City State
Finland Turku University Hospital Turku

Sponsors (7)
Lead Sponsor Collaborator
Turku University Hospital Helsinki University Central Hospital, Oulu University Hospital, Päijänne Tavastia Central Hospital, Satasairaala, Tampere University Hospital, Vaasa Central Hospital, Vaasa, Finland

Country where clinical trial is conducted

Finland, 

Outcome
Type Measure Description Time frame Safety issue
Primary re-intervention Requirement of re-intervention 3 months
Primary Pain after procedure Post procedural pain measured with VAS scale up to 3 months after the treatment
Primary Quality of life before after procedure Quality of life will be measured with Veins questionnaire up to 5 years
Primary Recur The recurring varicose veins up to 5 years
Secondary Surgical complications Infections, DVT, Pulmonary embolus will be reported 3 months
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