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

NCT06669260 | Not Yet Recruiting DMC

• 1 other identifier: TEThA
• Study Type: observational
• Target: 20
• Locations: 0 countries
• Sites: N/A

Brief Summary

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).

Conditions

Varicose Veins; Quality of Life; Laser

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

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

Secondary Outcomes (7)

• Hyperpigmentation

  Baseline, 30 days and 180 days

• Presence of induration

  30 days and 180 days

• Presence of Paresthesia

  30 days and 180 days

• Skin burns

  7 days

• Lymphedema

  30 days and 180 days

Study Arms (1)

TEThA technique

TEThA technique

Procedure: TEThA technique

Interventions

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.

TEThA technique

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Participants with tributary veins bigger than 2mm, presenting saphenous truncal incompetency scoring from C2 to C6 in CEAP

You may qualify if:

• Patients with varicose veins \> 2mm associated with reflux of great or small saphenous veins with CEAP C2 to C6

You may not qualify if:

• Patients under 18 years Acute or previous thrombophlebitis or deep vein thrombosis. Pregnant patient. Reject the Informed Consent Form.

Sponsors & Collaborators

• Nara Medeiros Cunha de Melo Vasconcelos: lead
• Gabriela de Oliveira Buril: collaborator
• Marcelo Halfen Grill: collaborator

Related Publications (4)

• Salim S, Machin M, Patterson BO, Onida S, Davies AH. Global Epidemiology of Chronic Venous Disease: A Systematic Review With Pooled Prevalence Analysis. Ann Surg. 2021 Dec 1;274(6):971-976. doi: 10.1097/SLA.0000000000004631.

  PMID: 33214466 BACKGROUND

• Lurie F, Passman M, Meisner M, Dalsing M, Masuda E, Welch H, Bush RL, Blebea J, Carpentier PH, De Maeseneer M, Gasparis A, Labropoulos N, Marston WA, Rafetto J, Santiago F, Shortell C, Uhl JF, Urbanek T, van Rij A, Eklof B, Gloviczki P, Kistner R, Lawrence P, Moneta G, Padberg F, Perrin M, Wakefield T. The 2020 update of the CEAP classification system and reporting standards. J Vasc Surg Venous Lymphat Disord. 2020 May;8(3):342-352. doi: 10.1016/j.jvsv.2019.12.075. Epub 2020 Feb 27.

  PMID: 32113854 BACKGROUND

• De Maeseneer MG, Kakkos SK, Aherne T, Baekgaard N, Black S, Blomgren L, Giannoukas A, Gohel M, de Graaf R, Hamel-Desnos C, Jawien A, Jaworucka-Kaczorowska A, Lattimer CR, Mosti G, Noppeney T, van Rijn MJ, Stansby G, Esvs Guidelines Committee, Kolh P, Bastos Goncalves F, Chakfe N, Coscas R, de Borst GJ, Dias NV, Hinchliffe RJ, Koncar IB, Lindholt JS, Trimarchi S, Tulamo R, Twine CP, Vermassen F, Wanhainen A, Document Reviewers, Bjorck M, Labropoulos N, Lurie F, Mansilha A, Nyamekye IK, Ramirez Ortega M, Ulloa JH, Urbanek T, van Rij AM, Vuylsteke ME. Editor's Choice - European Society for Vascular Surgery (ESVS) 2022 Clinical Practice Guidelines on the Management of Chronic Venous Disease of the Lower Limbs. Eur J Vasc Endovasc Surg. 2022 Feb;63(2):184-267. doi: 10.1016/j.ejvs.2021.12.024. Epub 2022 Jan 11. No abstract available.

  PMID: 35027279 BACKGROUND

• Vasconcelos NMCM, Kumakura HS, Grill MH, Silva MCE. Treatment of the small saphenous vein and tributary veins with endolaser associated with ultrasound-guided foam in a patient with post-thrombotic syndrome: presenting the TEThA technique. J Vasc Bras. 2024 Nov 29;23:e20230142. doi: 10.1590/1677-5449.202301422. eCollection 2024.

  PMID: 39629276 BACKGROUND

MeSH Terms

Conditions

Varicose Veins

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Central Study Contacts

Eduardo Ramacciotti, MD, PhD

CONTACT

+55 11 4040-8670; eduardoramacciotti@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: October 30, 2024
• First Posted: November 1, 2024
• Study Start: November 21, 2024
• Primary Completion: July 22, 2025
• Study Completion: July 22, 2025
• Last Updated: November 1, 2024

Record last verified: 2024-10