EICHORCondition: Varicose Veins · Sponsor: Center Of Phlebology
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Endovenous thermal ablation (EVTA), including radiofrequency ablation (RFA) and endovenous laser ablation (EVLA), is considered the main method for the treatment of symptomatic truncal vein reflux. However, there are controversial data concerning their efficacy and safety in ablating large saphenous veins because of high risk of heat-induced thrombosis (EHIT), incomplete ablation and recanalization.1-5 The use of vacuum evacuation of the remaining intraluminal blood during endovenous laser ablation allows to decrease the risk of intraoperative (carbonization and destruction of the fiber lens) and postoperative complications (EHIT, hyperpigmentation, "string" feeling) and leads to reduction of recovery because of short period of vein resorption. The aim of the study is to evaluate the safety and effectiveness of endovenous thermal ablation with or without vacuum evacuation for the treatment of incompetent large saphenous veins (\>15 mm).
This description comes directly from the study's public registry record.
Dmitrii N Alekseev, PhD · +996555521274 · dm.alekseev81@gmail.com
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Inclusion Criteria: * Age over 18 years * Varicose veins of the lower extremities with clinical class C2-C6 with a diameter of the GSV or SSV ≥ 15 mm in a standing position * Informed consent Exclusion Criteria: * pregnancy or lactation * malignant neoplasms * inability or unwillingness of any patient to wear compression stockings * hypersensitivity to lidocaine * concomitant diseases: diabetes mellitus, bronchial asthma, severe liver and kidney diseases, acute thrombosis and thrombophlebitis, skin and/or soft tissue infection, infectious diseases, obliterating peripheral arteriosclerosis, diabetic angiopathy, heart defects requiring surgical intervention, fever, toxic hyperthyroidism, obesity, tuberculosis, sepsis, blood cell composition disorder, all diseases requiring bed rest, heart disease with decompensation, known hereditary thrombophilia * period after treatment for alcohol addiction * sedentary lifestyle * history of acute deep vein thrombosis * history of superficial thrombophlebitis * history of drug or other addiction * use of oral contraceptives or other hormonal drugs
Reproduced word-for-word from the public registry record — the study team can answer questions about it.
| Clinic in Uruchye | Minsk, Belarus | Recruiting |
| Merci clinic | Minsk, Belarus | Recruiting |
| SANTE clinic | Minsk, Belarus | Recruiting |
| Center Of Phlebology | Bishkek, Chuy Region, Kyrgyzstan | Recruiting |
| Laser Surgery Center | Moscow, Russia | Recruiting |
| Innovative vascular centre | Saint Petersburg, Russia | Recruiting |
| Derzhavin Tambov State University | Tambov, Russia | Recruiting |
| Clinic of Modern Phlebology "VarikozOFF" | Tashkent, Uzbekistan | Recruiting |
| Clinic of Modern Phlebology "VarikozOFF" | Tashkent, Uzbekistan | Recruiting |
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Source record: clinicaltrials.gov/study/NCT06971068