Clinical trial NCT04645771: Safety and Efficacy Study of Endovenous Microwave Ablation for Treatment of Varicose Veins
Official title: Safety and Efficacy Study of Endovenous Microwave Ablation for Treatment of Varicose Veins
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Vascular Diseases, Peripheral
Venous Insufficiency of Leg
Varicose Veins of Lower Limb
Keywords: microwave ablation
varicose veins
traditional treatment
Lead sponsor: Chengdu University of Traditional Chinese Medicine
Sponsor class: OTHER
First posted: 2020-11-27
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: A total of 50 patients with varicose veins of lower extremities treated with microwave ablation catheter were selected to observe their venous closure rate and postoperative adverse reactions.
Primary purpose: TREATMENT

Brief 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.

Detailed 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.

Eligibility criteria: 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 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.

The investigators determined that intravenous therapy was not appropriate.

Primary outcomes:
measure: Technical Success at time of procedure
timeFrame: Immediately post-procedure
measure: Anatomical Success
timeFrame: 3days
measure: Anatomical Success
timeFrame: 12 months post-procedure
Secondary outcomes:
measure: Instrumental success
timeFrame: Immediately post-procedure
measure: Quality of Life score using EQ-5D questionnaire
timeFrame: Baseline, 1 month, 6 months and 12 months
measure: Quality of life score using the Chronic Venous Insufficiency Questionnaire(CIVIQ-14)
timeFrame: Baseline, 1 month, 6 months and 12 months
measure: Quality of life score using the Aberdeen Varicose Veins Questionnaire (AVVQ)
timeFrame: Baseline, 1 month, 6 months and 12 months
measure: Clinical Change using Venous Clinical Severity Score (VCSS)
timeFrame: Baseline, 1 month, 6 months and 12 months
measure: Time taken to return to work and normal activities
timeFrame: 10 days post-op
measure: Participants' satisfaction post-procedure
timeFrame: 3 days post-op
Other outcomes:
Locations:
city: Chengdu
country: China
facility: Hospital of Chengdu University of Traditional Chinese Medicine
state: Sichuan
Study officials:
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