About this trial
Endovenous laser thermoablation is a well-established alternative for the treatment of tributary veins. We believe that it is possible to improve the techniques described in the literature, aiming not only to allocate the laser fiber within the venous lumen, but mainly to transfix the vessel walls - a technique called TEThA (Transfixing Endovenous Thermal Ablation).
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
None
Disqualifiers
None
Trial population
Participants with tributary veins bigger than 2mm, presenting saphenous truncal incompetency scoring from C2 to C6 in CEAP
Trial design
Cohort
Prospective
Treatments tested in this trial
TEThA technique
Procedure/SurgeryPatient in an orthostatic position, previously marked varicose veins will be punctured with a tracing adjacent to them, surrounding their edges. Applying an augmented reality device and Doppler ultrasound (Doppler USG), the marking will be complemented in the supine position. These punctures will in turn be carried out using the TEThA technique - endovenous thermoablation of tributary veins by means of transfixation - and will be done sequentially as they are treated one by one with endo- and perivenous thermoablation under generous tumescence with 0.08% lidocaine in saline solution. The laser used to treat the tributary veins will also be 1470 nm and will be fired as the fiber is removed at a speed of 1 mm/sec and power ranging from 5 to 7 watts.
Treatment groups
Trial outcomes
Primary outcomes
Quality of Life score using Aberdeen Varicose Veins Questionnaire (AVVQ)
AVVQ is an easy-to-administer, self-administered instrument, it consists of 3 dimensions, which are physical, sociofunctional and psychological. It is interpreted through a score, which can vary between 0 and 100, with 0 representing no evidence of varicose veins and 100 the most serious problem associated with varicose veins.
Quality of life score using the Chronic Venous Insufficiency Questionnaire (CIVIQ)
CIVIQ-14 is a questionnaire based on three dimensions - pain, physical and psychological, based on a scale from 1 to 5 (no trouble, slight, moderate, considerable, severe). Based on inputs, Global Index Score (GIS) will be tabulated, ranging from 0 to 100 - the higher the value, the poorer the quality of life.
Secondary outcomes
Hyperpigmentation
Presence or absence of hyperpigmentation in the limb treated by a endovenous laser with TEThA tecnique (phototodocumentation, US Doppler)
Presence of induration
Induration noticed on the saphenous vein path (phototodocumentation, US Doppler)
Presence of Paresthesia
Presence or absence of paresthesia in the limb treated by endovenous laser TEThA technique
Skin burns
Presence or absence of skin burns in the limb treated by a endovenous laser with TEThA technique
Locations
Sponsors and contacts
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Nara Medeiros Cunha de Melo Vasconcelos
Lead sponsor
Science Valley Research Institute
Sponsor institution
Gabriela de Oliveira Buril
Collaborator
Marcelo Halfen Grill
Collaborator
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