Clinical Trials Logo

Clinical Trial 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.


Clinical Trial 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. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT04645771
Study type Interventional
Source Chengdu University of Traditional Chinese Medicine
Contact Chunshui He, Doctor
Phone 18981885601
Email chunshuihe@msn.com
Status Recruiting
Phase N/A
Start date February 4, 2021
Completion date December 5, 2022

See also
  Status Clinical Trial Phase
Not yet recruiting NCT05930587 - Effect of Cold Immersion on Patients With Varicose Vein N/A
Recruiting NCT04546750 - Prospective Cohort Study for Varicose Veins Incidence and Natural Course
Completed NCT05372146 - Great Saphenous Vein Sparing Segmental Radiofrequency Ablation in Varicose Veins Patients N/A
Recruiting NCT06124664 - Study of Venous Outflow From the Lower Limbs in Patients With Pelvic Varicosities
Completed NCT03613376 - Compression And Functional Ability After Endovenous Varicose Vein Treatment N/A
Completed NCT04148950 - Effects of Kinesio Taping Method on Functional Capacity and Quality of Life in Patients With Chronic Venous Disease N/A
Completed NCT04658901 - ACOART RF CLOSURE:Radiofrequency for Varicose Veins of Lower Extremity in China N/A
Not yet recruiting NCT04794712 - Evaluation of Pain Associated With Chronic Venous Insufficiency
Recruiting NCT05581524 - Vacuum Assisted Sclerotherapy Performed by Catheter N/A
Completed NCT04720027 - Long Term Study of 3 Radiofrequency Devices
Completed NCT05058989 - The Evaluation of the Pathophysiology of Varicose Veins in Pregnancy
Recruiting NCT03035747 - Ongoing Registry of Treatment of Chronic Venous Diseases
Recruiting NCT05851183 - Effect of Vitis Vinifera Seed Extract on Venous Reflux Time in Varicose Vein Phase 4
Completed NCT05468450 - RCT Comparing EVLA Versus Polidocanol Foam in the Treatment of SSV Insufficiency N/A
Completed NCT03722134 - Mechanochemical Ablation vs Thermal Ablation N/A
Active, not recruiting NCT04726124 - MicrOwave and laSer ablaTion Study (MOST Study) N/A
Active, not recruiting NCT06387264 - Compont - Varicose Veins of the Lower Extremities N/A
Recruiting NCT03293836 - Venous Ulcer: Endovenous Radiofrequency Treatment Trial N/A
Enrolling by invitation NCT06175546 - Daily Duration of Compression Treatment in Patients With Symptomatic Chronic Venous Disease N/A
Not yet recruiting NCT05654233 - The Study of Reducing Adverse Effects After Radiofrequency Ablation Combined With Sclerotherapy N/A