EVLA and Optimal Timing of Sclerotherapy
FinnTrunk
FinnTrunk, EVLA and Optimal Timing of Sclerotherapy
1 other identifier
interventional
350
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Mar 2021
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 24, 2021
CompletedFirst Posted
Study publicly available on registry
March 1, 2021
CompletedStudy Start
First participant enrolled
March 15, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 15, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
March 15, 2030
March 1, 2021
February 1, 2021
6 years
February 24, 2021
February 24, 2021
Conditions
Outcome Measures
Primary Outcomes (4)
re-intervention
Requirement of re-intervention
3 months
Pain after procedure
Post procedural pain measured with VAS scale
up to 3 months after the treatment
Quality of life before after procedure
Quality of life will be measured with Veins questionnaire
up to 5 years
Recur
The recurring varicose veins
up to 5 years
Secondary Outcomes (1)
Surgical complications
3 months
Study Arms (2)
EVLA only
ACTIVE COMPARATOROnly main trunk/trunks with venous reflux will be treated
EVLA and sclerotherapy of tributaries
ACTIVE COMPARATORMain trunk/trunks with venous reflux will be treated combined with foam sclerotherapy
Interventions
The aim is to combine the significance of for sclerotherapy at the primary EVLA treatment
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- No severe comorbidities. Previous DVT.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Turku University Hospitallead
- Helsinki University Central Hospitalcollaborator
- Oulu University Hospitalcollaborator
- Tampere University Hospitalcollaborator
- Päijänne Tavastia Central Hospitalcollaborator
- Satasairaalacollaborator
- Vaasa Central Hospital, Vaasa, Finlandcollaborator
Study Sites (1)
Turku University Hospital
Turku, 20520, Finland
Related Publications (1)
Viljamaa J, Firoozi K, Venermo M, Pokela M, Pihlaja T, Halmesmaki K, Hakovirta H. A study protocol for comparing the treatment of varicose tributaries either concomitantly with or separately from endovenous laser ablation of the incompetent saphenous trunk (the FinnTrunk Study). A multicenter parallel-group randomized controlled study. PLoS One. 2023 May 23;18(5):e0285823. doi: 10.1371/journal.pone.0285823. eCollection 2023.
PMID: 37220130DERIVED
Study Officials
- STUDY CHAIR
Harri Hakovirta, Professor
University of Turku
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER GOV
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- MD
Study Record Dates
First Submitted
February 24, 2021
First Posted
March 1, 2021
Study Start
March 15, 2021
Primary Completion (Estimated)
March 15, 2027
Study Completion (Estimated)
March 15, 2030
Last Updated
March 1, 2021
Record last verified: 2021-02
Data Sharing
- IPD Sharing
- Will not share