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Not Yet RecruitingNCT06669260

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

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

Status
Not Yet Recruiting
Phase
Study type
Observational
Enrollment
20 (estimated)
Sponsor
Nara Medeiros Cunha de Melo Vasconcelos · Academic / Other
Sex
All
Age
18 Years – 90 Years
Healthy volunteers
Not accepted

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).

Detailed description

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.

Conditions

Interventions

TypeNameDescription
PROCEDURETEThA techniquePatient 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.

Timeline

Start date
2024-11-21
Primary completion
2025-07-22
Completion
2025-07-22
First posted
2024-11-01
Last updated
2024-11-01

Source: ClinicalTrials.gov record NCT06669260. Inclusion in this directory is not an endorsement.

Evaluating QoL and Postoperative Complications Using TEThA Technique in the Treatment of Tributary Veins (NCT06669260) · Clinical Trials Directory