Evaluating QoL and Postoperative Complications Using TEThA Technique in the Treatment of Tributary Veins

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-90
SponsorNara Medeiros Cunha de Melo Vasconcelos

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 volunteers

Qualifiers

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

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • TEThA technique

    Procedure/Surgery

    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.

Treatment groups

20 Participants
are divided into 1 treatment group
Group A: TEThA technique1 intervention

Trial outcomes

Primary outcomes

1

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
2

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

Secondary outcomes

1

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
2

Presence of induration

Induration noticed on the saphenous vein path (phototodocumentation, US Doppler)

Time frame
30 days and 180 days
3

Presence of Paresthesia

Presence or absence of paresthesia in the limb treated by endovenous laser TEThA technique

Time frame
30 days and 180 days
4

Skin burns

Presence or absence of skin burns in the limb treated by a endovenous laser with TEThA technique

Time frame
7 days

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

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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