NCT04645771

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 50 (estimated)
• Sponsor: Chengdu University of Traditional Chinese Medicine · Academic / Other
• Sex: All
• Age: 18 Years – 90 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Vascular Diseases, Peripheral
• Venous Insufficiency of Leg
• Varicose Veins of Lower Limb

Interventions

Type	Name	Description
PROCEDURE	Questionnaires	Questionnaires to assess the quality of life (EQ-5D, CVVQ, CIVIQ, AVVQ, Patient satisfaction survey)

Timeline

• Start date: 2021-02-04
• Primary completion: 2022-11-01
• Completion: 2022-12-05
• First posted: 2020-11-27
• Last updated: 2022-11-08

Locations

1 site across 1 country: China