Venous RefluxFinnTrunkNCT04774939
EVLA and Optimal Timing of Sclerotherapy
A study testing Endovenous laser ablation in people with Venous Reflux, run by Turku University Hospital at 1 site in Finland.
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. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Venous Reflux
- What is being tested?
- Endovenous laser ablation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 350 participants
- Where
- 1 siteFinland
- Study dates
- 15 Mar 2021to 15 Mar 2030
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- No severe comorbidities. Previous DVT.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Finland1 site
Turku University Hospital
Turku, 20520
Harri Hakovirta, Professor, +35823130000, harri.hakovirta@tyks.fi
Khalil Firoozi, MD, +35823130000, khalil.firoozi@tyks.fi
About this study
Official title: FinnTrunk, 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.
Read the 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
- Being tested
- Endovenous laser ablation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Endovenous laser ablationProcedure or surgery
Also called Endovenous laser ablation combined with foam sclerotherapy of varicose tributaries
The aim is to combine the significance of for sclerotherapy at the primary EVLA treatment
| Study group | Role | What they receive |
|---|---|---|
| EVLA only | Active comparator | Only main trunk/trunks with venous reflux will be treated Receives: Procedure: Endovenous laser ablation |
| EVLA and sclerotherapy of tributaries | Active comparator | Main trunk/trunks with venous reflux will be treated combined with foam sclerotherapy Receives: Procedure: Endovenous laser ablation |
What is being measured
The primary outcome is the main question the study is designed to answer.
re-intervention
Requirement of re-intervention
Measured: 3 months
Pain after procedure
Post procedural pain measured with VAS scale
Measured: up to 3 months after the treatment
Quality of life before after procedure
Quality of life will be measured with Veins questionnaire
Measured: up to 5 years
Recur
The recurring varicose veins
Measured: up to 5 years
Secondary outcomes (1)
Surgical complications
Infections, DVT, Pulmonary embolus will be reported
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Mar 2021
- Study start15 Mar 2021 (estimated)
- Primary completion15 Mar 2027 (estimated)
- Study completion15 Mar 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Venous RefluxStudies of the same condition, open and under way.
- More trials run by Turku University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 350 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Turku University Hospital
- Sponsor type
- Other government
- Collaborators
- Helsinki University Central Hospital, Oulu University Hospital, Tampere University Hospital, Päijänne Tavastia Central Hospital, Satasairaala, Vaasa Central Hospital, Vaasa, Finland
- Responsible party
- Principal investigator, Khalil Firoozi, Turku University Hospital
- Investigators
- Harri Hakovirta, Professor, Study chair, University of Turku
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04774939
- Sponsor's protocol ID
- 93 /1801/2020
- Acronym
- FinnTrunk
- Status last verified
- Feb 2021
- First submitted
- 24 Feb 2021
- Last updated
- 1 Mar 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 37220130
Study at a glance
From the registry record, last updated by the sponsor on 1 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- FinnTrunk, EVLA and Optimal Timing of Sclerotherapy
- ClinicalTrials.gov ID
- NCT04774939
- Acronym / sponsor ID
- FinnTrunk / 93 /1801/2020
- Conditions
- Venous Reflux
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 350 participants (estimated)
- Lead sponsor
- Turku University HospitalOther government
- Collaborators
- Helsinki University Central Hospital, Oulu University Hospital, Tampere University Hospital, Päijänne Tavastia Central Hospital, Satasairaala, Vaasa Central Hospital, Vaasa, Finland
- Study start
- 15 Mar 2021 (estimated)
- Primary completion
- 15 Mar 2027 (estimated)
- Study completion
- 15 Mar 2030 (estimated)
- First posted
- 1 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| EVLA only | Active comparator | Procedure: Endovenous laser ablationOnly main trunk/trunks with venous reflux will be treated |
| EVLA and sclerotherapy of tributaries | Active comparator | Procedure: Endovenous laser ablationMain trunk/trunks with venous reflux will be treated combined with foam sclerotherapy |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- No severe comorbidities. Previous DVT.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Endovenous laser ablationAlso: Endovenous laser ablation combined with foam sclerotherapy of varicose tributariesThe aim is to combine the significance of for sclerotherapy at the primary EVLA treatment | Procedure or surgery | EVLA and sclerotherapy of tributaries, EVLA only |
Primary outcome
re-intervention
Time frame: 3 months
Requirement of re-intervention
Pain after procedure
Time frame: up to 3 months after the treatment
Post procedural pain measured with VAS scale
Quality of life before after procedure
Time frame: up to 5 years
Quality of life will be measured with Veins questionnaire
Recur
Time frame: up to 5 years
The recurring varicose veins
1 secondary outcome
Surgical complications
Time frame: 3 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Mar 2021.
- Derived from this study: PubMed 37220130Viljamaa 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Harri Hakovirta, Professor study chair
University of Turku
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Endovenous laser ablation in people with Venous Reflux, run by Turku University Hospital at 1 site in Finland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 1 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Finland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Harri Hakovirta, Professor (+358405918811, haheha@utu.fi), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
re-intervention (time frame: 3 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04774939, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Mar 2021.