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

NCT ID: NCT04645771

Last Updated: 2022-11-08

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-02-04
• Study Completion Date: 2022-12-05

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.

Conditions

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Microwave ablations

A total of 50 patients with varicose veins of lower extremities treated with microwave ablation catheter were selected to observe their annual venous closure rate and postoperative adverse reactions.

Group Type: EXPERIMENTAL

Questionnaires

Intervention Type: PROCEDURE

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

Interventions

Questionnaires

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

Intervention Type: PROCEDURE

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Chengdu University of Traditional Chinese Medicine

OTHER

Sponsor Role: lead

Responsible Party

Chunshui He

Director of Vascular Surgery in ChengduUTCM

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Hospital of Chengdu University of Traditional Chinese Medicine

Chengdu, Sichuan, China

Site Status: RECRUITING

Countries

China

Central Contacts

Chunshui He, Doctor

Role: CONTACT

chunshuihe@msn.com

18981885601

Facility Contacts

Ye Gao, Master

Role: primary

18883367703@163.com

18883367703

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Zhang L, Lin Y, Geng C, Huang W, Yang Q, He C, Zeng W. Safety and efficacy of endovenous microwave ablation for treatment of varicose veins of the lower limbs in China: A prospective registered clinical trial. Vascular. 2024 Aug 26:17085381241273225. doi: 10.1177/17085381241273225. Online ahead of print.

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Other Identifiers

ChengduUTCMvs

Identifier Type: -

Identifier Source: org_study_id