An observational study in Varicose Veins, Quality of Life and Laser, sponsored by Nara Medeiros Cunha de Melo Vasconcelos. Not yet recruiting. Open to participants aged 18 Years to 90 Years. Per ClinicalTrials.gov, last updated 2024-11-01.
Sponsored by Nara Medeiros Cunha de Melo Vasconcelos · Observational
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).
Endovenous laser thermoablation is an alternative for the treatment of tributary veins that is not yet one of the main alternatives in our specialty's consensus. In order to treat tributary veins applying laser, several punctures and the complete placement of introducer catheters are recommended in order to position the endolaser fiber in the lumen of the varicose vein before performing thermoablation of the saphenous veins. However, we believe that it is possible to perform an adequate treatment with a smaller number of punctures, aiming not only to place the laser fiber inside the venous lumen, but mainly to transfix the vessel walls - a technique called TEThA (Transfixing Endovenous Thermal Ablation). Our aim is to carry out a prospective cohort study to assess the Aberdeen score in patients undergoing the TEThA technique for the treatment of tributary veins.
253 studies on the registry are indexed under Varicose Veins; 35 are open to participants now.
This study's planned enrollment of 20 is below the median of 124 across 79 observational studies indexed under Varicose Veins.
Browse Varicose Veins studies →This is the only study on the registry with Nara Medeiros Cunha de Melo Vasconcelos as lead sponsor.
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Participants with tributary veins bigger than 2mm, presenting saphenous truncal incompetency scoring from C2 to C6 in CEAP
Patients with varicose veins > 2mm associated with reflux of great or small saphenous veins with CEAP C2 to C6
Exclusion Criteria:
Patients under 18 years Acute or previous thrombophlebitis or deep vein thrombosis. Pregnant patient. Reject the Informed Consent Form.
TEThA technique
Procedure: TEThA technique
Patient 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.
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.
Time frame: Baseline, Timepoints post-procedire: 1 month, 3 months, 6 months
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.
Time frame: Timepoints post-procedire: 1 month, 3 months, 6 months
Hyperpigmentation
Presence or absence of hyperpigmentation in the limb treated by a endovenous laser with TEThA tecnique (phototodocumentation, US Doppler)
Time frame: Baseline, 30 days and 180 days
Presence of induration
Induration noticed on the saphenous vein path (phototodocumentation, US Doppler)
Time frame: 30 days and 180 days
Presence of Paresthesia
Presence or absence of paresthesia in the limb treated by endovenous laser TEThA technique
Time frame: 30 days and 180 days
Skin burns
Presence or absence of skin burns in the limb treated by a endovenous laser with TEThA technique
Time frame: 7 days
Lymphedema
Presence or absence of lymphedema diagnosed by exam of lymphoscintigraphy in the limb treated by endovenous laser TEThA technique
Time frame: 30 days and 180 days
Sclerothrombus
Presence of Sclerothrombus (US doppler)
Time frame: 7 days
Complementary treatment
Percentage of participants with residual veins
Time frame: 180 days
No study locations are listed for this record.
Plan to share: Undecided
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