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

Varicose Veins of Lower Limb Clinical Trial

— EMINENCE  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04645771
• Other study ID #: ChengduUTCMvs
• Status: Recruiting
• Phase: N/A
• Start date: February 4, 2021
• Est. completion date: December 5, 2022

Study information

• Verified date: November 2022
• Source: Chengdu University of Traditional Chinese Medicine
• Contact: Chunshui He, Doctor
• Phone: 18981885601
• Email: chunshuihe[@]msn.com
• Is FDA regulated: No
• Study type: Interventional

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: December 5, 2022
• Est. primary completion date: November 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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.

Related Conditions & MeSH terms

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

Intervention

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

Locations

Country	Name	City	State
China	Hospital of Chengdu University of Traditional Chinese Medicine	Chengdu	Sichuan

Sponsors (1)

Lead Sponsor	Collaborator
Chengdu University of Traditional Chinese Medicine

Country where clinical trial is conducted

China, 

References & Publications (10)

Brace CL. Microwave ablation technology: what every user should know. Curr Probl Diagn Radiol. 2009 Mar-Apr;38(2):61-7. doi: 10.1067/j.cpradiol.2007.08.011. Review. — View Citation

Gloviczki P, Comerota AJ, Dalsing MC, Eklof BG, Gillespie DL, Gloviczki ML, Lohr JM, McLafferty RB, Meissner MH, Murad MH, Padberg FT, Pappas PJ, Passman MA, Raffetto JD, Vasquez MA, Wakefield TW; Society for Vascular Surgery; American Venous Forum. The c — View Citation

Lawson JA, Gauw SA, van Vlijmen CJ, Pronk P, Gaastra MTW, Tangelder MJ, Mooij MC. Prospective comparative cohort study evaluating incompetent great saphenous vein closure using radiofrequency-powered segmental ablation or 1470-nm endovenous laser ablation — View Citation

Liu D, Brace CL. Evaluation of tissue deformation during radiofrequency and microwave ablation procedures: Influence of output energy delivery. Med Phys. 2019 Sep;46(9):4127-4134. doi: 10.1002/mp.13688. Epub 2019 Jul 17. — View Citation

Proebstle TM, Vago B, Alm J, Göckeritz O, Lebard C, Pichot O. Treatment of the incompetent great saphenous vein by endovenous radiofrequency powered segmental thermal ablation: first clinical experience. J Vasc Surg. 2008 Jan;47(1):151-156. doi: 10.1016/j — View Citation

Quehe P, Alavi Z, Kurylo-Touz T, Saliou AH, Badra A, Baudino L, Gladu G, Ledan F, Haudebourg R, Gestin S, Bressollette L. Endovenous Celon radiofrequency-induced thermal therapy of great saphenous vein: A retrospective study with a 3-year follow-up. SAGE — View Citation

Simon CJ, Dupuy DE, Mayo-Smith WW. Microwave ablation: principles and applications. Radiographics. 2005 Oct;25 Suppl 1:S69-83. Review. — View Citation

Vogl TJ, Naguib NN, Lehnert T, Nour-Eldin NE. Radiofrequency, microwave and laser ablation of pulmonary neoplasms: clinical studies and technical considerations--review article. Eur J Radiol. 2011 Feb;77(2):346-57. doi: 10.1016/j.ejrad.2009.07.034. Epub 2 — View Citation

Yang L, Wang X, Wei Z, Zhu C, Liu J, Han Y. The clinical outcomes of endovenous microwave and laser ablation for varicose veins: A prospective study. Surgery. 2020 Nov;168(5):909-914. doi: 10.1016/j.surg.2020.06.035. Epub 2020 Aug 10. — View Citation

Yang L, Wang XP, Su WJ, Zhang Y, Wang Y. Randomized clinical trial of endovenous microwave ablation combined with high ligation versus conventional surgery for varicose veins. Eur J Vasc Endovasc Surg. 2013 Oct;46(4):473-9. doi: 10.1016/j.ejvs.2013.07.004 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Technical Success at time of procedure	Use duplex ultrasound assess the occlusion of treated vein post-procedure,record the rate of occlusion of treated vein post-procedure	Immediately post-procedure
Primary	Anatomical Success	Use duplex ultrasound verify the occlusion of treated vessel and record the rate of occlusion of treated vessel	3days
Primary	Anatomical Success	Use duplex ultrasound verify the occlusion of treated vessel and record the rate of occlusion of treated vessel	12 months post-procedure
Secondary	Instrumental success	successful delivery of endovenous microwave ablation catheter in right place and successful withdrawal after microwave treatment is defined as Instrumental success	Immediately post-procedure
Secondary	Quality of Life score using EQ-5D questionnaire	EQ-5D is used to assess quality of life based on Mobility, Self-care, Usual Activities, Pain/Discomfort and Anxiety, rated at 5 levels: no problems, slight problems, moderate problems, severe problems, unable to perform activity. Inputs from this questionnaire is used to observe the changes in quality of life over the whole test procedure	Baseline, 1 month, 6 months and 12 months
Secondary	Quality of life score using the Chronic Venous Insufficiency Questionnaire(CIVIQ-14)	CIVIQ-14 is a questionnaire based on three dimensions - pain, physical and psychological, based on a scale from 1 to 5 (no trouble, slight, moderate, considerable, severe).Based on inputs, CIVIQ-14 will be tabulated, ranging from 0 to 100 - the higher the value, the poorer the quality of life.In order to observe the changes in quality of life over the whole test procedure.	Baseline, 1 month, 6 months and 12 months
Secondary	Quality of life score using the Aberdeen Varicose Veins Questionnaire (AVVQ)	To measure health status of varicose vein participants based on symptoms and impact on daily activities. A total score ranging from 0 to 30 will be tabulated, with 30 being worst quality of life.In order to observe the changes in quality of life over the whole test procedure.	Baseline, 1 month, 6 months and 12 months
Secondary	Clinical Change using Venous Clinical Severity Score (VCSS)	VCSS evaluates the severity of hallmarks of venous disease - 0 (none), 1 (Mild) , 2(Moderate), 3 (Severe).Record the score separately to observe the changes in quality of life over the whole test procedure.	Baseline, 1 month, 6 months and 12 months
Secondary	Time taken to return to work and normal activities	Investigators will make a call to follow up the day when the participants return to work and normal activities	10 days post-op
Secondary	Participants' satisfaction post-procedure	To rate satisfaction with overall teatment regime with a numerical scale of 0 (least satisfied) to 10 (most satisfied) through an app named Recovery+	3 days post-op