Vacuum-assisted Laser Treatment for Varicose Veins
Vacuum-assisted Laser Ablation (VALA) for Treatment of Large Saphenous Veins
Recruiting
N/AInterventional Study
Varicose Veins
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
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Review the details below, then apply to join this clinical trial.
At a Glance
Age
18 – 90
Sex
Any
Study type
Interventional
Purpose
Treatment
Participants needed
184 (estimated)
Sponsor
Center Of Phlebology · Research network
Who this trial is looking for
This trial is looking for adults with varicose veins in their legs. Participants will receive a laser treatment that may or may not include a special vacuum technique.
Are You a Good Fit for This Trial?
You may be able to join if
I am over 18 years old.
I have varicose veins in my legs that are at least 15 mm wide.
I agree to take part in the trial.
You may not be able to join if
I am pregnant or breastfeeding.
I have cancer.
I cannot or will not wear compression stockings.
I am allergic to lidocaine.
I have certain serious health conditions like diabetes or severe asthma.
I have a history of deep vein thrombosis or superficial thrombophlebitis.
I am living a sedentary lifestyle.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer a few quick questions to see if you may meet the eligibility requirements.
Endovenous thermal ablation (EVTA), including radiofrequency ablation (RFA) and endovenous laser ablation (EVLA), is considered the main method for the treatment of symptomatic truncal vein reflux. However, there are controversial data concerning their efficacy and safety in ablating large saphenous veins because of high risk of heat-induced thrombosis (EHIT), incomplete ablation and recanalizatio…
Endovenous thermal ablation (EVTA), including radiofrequency ablation (RFA) and endovenous laser ablation (EVLA), is considered the main method for the treatment of symptomatic truncal vein reflux. However, there are controversial data concerning their efficacy and safety in ablating large saphenous veins because of high risk of heat-induced thrombosis (EHIT), incomplete ablation and recanalization.1-5 The use of vacuum evacuation of the remaining intraluminal blood during endovenous laser ablation allows to decrease the risk of intraoperative (carbonization and destruction of the fiber lens) and postoperative complications (EHIT, hyperpigmentation, "string" feeling) and leads to reduction of recovery because of short period of vein resorption. The aim of the study is to evaluate the safety and effectiveness of endovenous thermal ablation with or without vacuum evacuation for the treatment of incompetent large saphenous veins (\>15 mm).
Trial Locations
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Eligibility Criteria
Inclusion Criteria:
* Age over 18 years
* Varicose veins of the lower extremities with clinical class C2-C6 with a diameter of the GSV or SSV ≥ 15 mm in a standing position
* Informed consent
Exclusion Criteria:
* pregnancy or lactation
* malignant neoplasms
* inability or unwillingness of any pa…
Inclusion Criteria:
* Age over 18 years
* Varicose veins of the lower extremities with clinical class C2-C6 with a diameter of the GSV or SSV ≥ 15 mm in a standing position
* Informed consent
Exclusion Criteria:
* pregnancy or lactation
* malignant neoplasms
* inability or unwillingness of any patient to wear compression stockings
* hypersensitivity to lidocaine
* concomitant diseases: diabetes mellitus, bronchial asthma, severe liver and kidney diseases, acute thrombosis and thrombophlebitis, skin and/or soft tissue infection, infectious diseases, obliterating peripheral arteriosclerosis, diabetic angiopathy, heart defects requiring surgical intervention, fever, toxic hyperthyroidism, obesity, tuberculosis, sepsis, blood cell composition disorder, all diseases requiring bed rest, heart disease with decompensation, known hereditary thrombophilia
* period after treatment for alcohol addiction
* sedentary lifestyle
* history of acute deep vein thrombosis
* history of superficial thrombophlebitis
* history of drug or other addiction
* use of oral contraceptives or other hormonal drugs
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