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NCT Number: NCT06669260

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

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).

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Key information

Conditions

Varicose Veins Cardiovascular Diseases LASER Quality of Life Vascular Diseases

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Observational

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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.

Treatment and study plan

TEThA technique

Procedure

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.

Primary outcomes

  1. Quality of Life score using Aberdeen Varicose Veins Questionnaire (AVVQ)

    Time frame: Baseline, Timepoints post-procedire: 1 month, 3 months, 6 months

    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.

  2. Quality of life score using the Chronic Venous Insufficiency Questionnaire (CIVIQ)

    Time frame: Timepoints post-procedire: 1 month, 3 months, 6 months

    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

  1. Hyperpigmentation

    Time frame: Baseline, 30 days and 180 days

    Presence or absence of hyperpigmentation in the limb treated by a endovenous laser with TEThA tecnique (phototodocumentation, US Doppler)

  2. Presence of induration

    Time frame: 30 days and 180 days

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

  3. Presence of Paresthesia

    Time frame: 30 days and 180 days

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

  4. Skin burns

    Time frame: 7 days

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

  5. Lymphedema

    Time frame: 30 days and 180 days

    Presence or absence of lymphedema diagnosed by exam of lymphoscintigraphy in the limb treated by endovenous laser TEThA technique

  6. Sclerothrombus

    Time frame: 7 days

    Presence of Sclerothrombus (US doppler)

  7. Complementary treatment

    Time frame: 180 days

    Percentage of participants with residual veins

Study contacts

Contact information is provided by the study sponsor or research team.

Eduardo Ramacciotti, MD, PhD

CONTACT

[email protected]

+55 11 4040-8670

Sponsors and collaborators

Lead sponsor

Nara Medeiros Cunha de Melo Vasconcelos

Other

Collaborators

  • Gabriela de Oliveira Buril
  • Marcelo Halfen Grill

Registry information

Official study title

Prospective Study to Evaluate QoL Scores and Post-operative Complications Using TEThA (Transfixing Endovenous Thermal Ablation) Technique in Tributary Veins Treatment

Acronym: TEThA

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Nov 1, 2024
Registry last updated
Nov 1, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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