Safety and Efficacy Study of Endovenous Microwave Ablation for Treatment of Varicose Veins (EMINENCE)

  • STATUS
    Recruiting
  • End date
    Dec 5, 2022
  • participants needed
    50
  • sponsor
    Chengdu University of Traditional Chinese Medicine
Updated on 29 May 2022

Summary

The purpose of this study was to evaluate the efficacy and safety of microwave ablation catheter in the treatment of varicose veins in lower extremities,meanwhile, to compare the quality of subjects'lives before and after treatment.

Description

The chronic venous insufficiency of lower extremities (chronic venous insufficiency, CVI) is a set of a series of clinical syndrome caused by venous reflux, common symptoms are heaviness, fatigue, swelling, burning sentation, itching, pain, etc.The main causes of superficial varicose veins are weakness of superficial vein wall, insufficiency or defect of vein valve closure and increased pressure inside veins.The weakness of venous wall, the decreasing of flexibility, venous valve defects the the poor structure, be related with genetic factor, belong to "primary" inferior venous valves' incomplete closure.The influencing factors of primary valve insufficiency include heavy physical labor, long standing or sitting work, obesity, pregnancy, chronic constipation, and chronic cough.Varicose veins secondary to a history of venous thrombosis of the lower extremities, venous system obstruction and increased venous pressure caused by circulating blood volume exceeding reflux load are secondary.When the valve of the great saphenous vein at the junction of the saphenous vein is damaged and closed incompletely, the valve function of the distal and perforating vein can be affected step by step, and the small saphenous vein can also be affected through its branch vein.Because the superficial vein wall's muscle layer is thin and their surrounding lackness of connective tissue, blood regurgitation can cause the venous lumen to thicken, tortuosity and lengthen, presenting as superficial varicose veins.Because of the severe venous pressure of lower extremity,the vascular permeability of football boots is increasing,resulting the appearance of a large number of blood capillary hyperplasia.Due to a large number of fibrinogen hindered the exchange between capillary and the surrounding tissue, the nutritional change of subcutaneous tissue occured,including skin pigmentation, eczema, dermatitis, subcutaneous lipid sclerosis and ulceration.

The traditional treatments of lower extremity varicose veins,including high ligation and stripping of great saphenous vein,varicose vein's resection and ligation of perforating vein,can cause large trauma,huge pain,limitation of activity and long convalescence and aesthetic problems,etc.As a consequence,a variety of minimally invasive method with small wound,little pain and early recovery are prevalently applied in clinical, also achieved plenty of good therapeutic effect.According to the different mechanism of minimally invasive treatment, it can be divided into two categories: physical injury (laser closure, radiofrequency closure, microwave treatment, electrocoagulation, transparent direct rotation, laparoscopic great saphenous vein resection, etc.) and chemical injury (sclerosing agent injection).

Clinical observation in our department found that the pain, bruising, numbness, and number of incisions after microwave ablation were all lower than those of traditional high position ligation and extraction with laser closure.

The purpose of this study is to report a monocentricity, prospective Chinese experience using the ECO Varicose Veins Therapeutic Unit from ECO (Nanjing ECO Microwave System Co.Ltd) for Endovenous Microwave Ablation (EMA) to treat primary great and short saphenous vein reflux and to evaluate its safety, efficacy and life quality.

Details
Condition Vascular Diseases, Peripheral, Venous Insufficiency of Leg, Varicose Veins of Lower Limb
Treatment Questionnaires
Clinical Study IdentifierNCT04645771
SponsorChengdu University of Traditional Chinese Medicine
Last Modified on29 May 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

Age >18 years, and <90 years ,and able to understand the requirements of the study and provide informed consent and accept the exams and follow-up
C2 - C5 varicose veins / CVI Symptomatic primary GSV, SSV or AASV incompetence, with reflux
>0.5 seconds on colour duplex, including one or more of the following symptoms: aching
throbbing, heaviness,fatigue, pruritus, night cramps, restlessness, generalized pain or
discomfort, swelling
Patients who has GSV, SSV AASV diameters of 3mm to 12mm in the standing postition
Only one limb of each patient was included in the study

Exclusion Criteria

Current DVT or history of DVT. Recurrent varicose veins. Pregnant patients. Arterial
disease (ABPI <0.8). Patients who are unwilling to participate this test. Inability or
The investigators determined that intravenous therapy was not appropriate
unwillingness to complete questionnaires. Adverse reaction to sclerosant or cyanoacrylate
GSV, SSV or AASV severely tortuous. Infectious disease. Life expectancy < 1 year. Current
regular use of systemic anticoagulation (e.g. warfarin, heparin). Daily use of narcotic
analgesia or NSAIDS to control pain associated with venous disease
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