EVLA and Optimal Timing of Sclerotherapy
ConditionVenous Reflux
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-99
SponsorTurku University Hospital
About this trial
The aim of the study is to investigate the optimal timing of sclerotherapy for treatment of varicose tributaries on EVLA (endogenous laser ablation) patients.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
No severe comorbidities. Previous DVT.
Trial design
Design model
Parallel
Treatments tested in this trial
Endovenous laser ablation
Procedure/SurgeryThe aim is to combine the significance of for sclerotherapy at the primary EVLA treatment
Treatment groups
350 Participants
are divided into 2 treatment groupsGroup A: EVLA onlyActive comparator 1 intervention
Group B: EVLA and sclerotherapy of tributariesActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
re-intervention
Requirement of re-intervention
Time frame
3 months2
Pain after procedure
Post procedural pain measured with VAS scale
Time frame
up to 3 months after the treatment3
Quality of life before after procedure
Quality of life will be measured with Veins questionnaire
Time frame
up to 5 years4
Recur
The recurring varicose veins
Time frame
up to 5 yearsSecondary outcomes
1
Surgical complications
Infections, DVT, Pulmonary embolus will be reported
Time frame
3 monthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Turku University Hospital
Lead sponsor
Helsinki University Central Hospital
Collaborator
Oulu University Hospital
Collaborator
Tampere University Hospital
Collaborator
Päijänne Tavastia Central Hospital
Collaborator
Satasairaala
Collaborator
Vaasa Central Hospital, Vaasa, Finland
Collaborator
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: