Safety and Efficacy Study of Endovenous Microwave Ablation for Treatment of Varicose Veins (EMINENCE)
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| ClinicalTrials.gov Identifier: NCT04645771 |
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Recruitment Status :
Recruiting
First Posted : November 27, 2020
Last Update Posted : May 16, 2022
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| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Vascular Diseases, Peripheral Venous Insufficiency of Leg Varicose Veins of Lower Limb | Procedure: Questionnaires | Not Applicable |
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 Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 50 participants |
| Allocation: | N/A |
| Intervention Model: | Single Group Assignment |
| 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. |
| Masking: | None (Open Label) |
| Primary Purpose: | Treatment |
| Official Title: | Safety and Efficacy Study of Endovenous Microwave Ablation for Treatment of Varicose Veins |
| Actual Study Start Date : | February 4, 2021 |
| Estimated Primary Completion Date : | September 5, 2022 |
| Estimated Study Completion Date : | December 5, 2022 |
| Arm | Intervention/treatment |
|---|---|
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Experimental: 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.
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Procedure: Questionnaires
Questionnaires to assess the quality of life (EQ-5D, CVVQ, CIVIQ, AVVQ, Patient satisfaction survey) |
- Technical Success at time of procedure [ Time Frame: Immediately post-procedure ]Use duplex ultrasound assess the occlusion of treated vein post-procedure,record the rate of occlusion of treated vein post-procedure
- Anatomical Success [ Time Frame: 3days ]Use duplex ultrasound verify the occlusion of treated vessel and record the rate of occlusion of treated vessel
- Anatomical Success [ Time Frame: 12 months post-procedure ]Use duplex ultrasound verify the occlusion of treated vessel and record the rate of occlusion of treated vessel
- Instrumental success [ Time Frame: Immediately post-procedure ]successful delivery of endovenous microwave ablation catheter in right place and successful withdrawal after microwave treatment is defined as Instrumental success
- Quality of Life score using EQ-5D questionnaire [ Time Frame: Baseline, 1 month, 6 months and 12 months ]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
- Quality of life score using the Chronic Venous Insufficiency Questionnaire(CIVIQ-14) [ Time Frame: Baseline, 1 month, 6 months and 12 months ]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.
- Quality of life score using the Aberdeen Varicose Veins Questionnaire (AVVQ) [ Time Frame: Baseline, 1 month, 6 months and 12 months ]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.
- Clinical Change using Venous Clinical Severity Score (VCSS) [ Time Frame: Baseline, 1 month, 6 months and 12 months ]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.
- Time taken to return to work and normal activities [ Time Frame: 10 days post-op ]Investigators will make a call to follow up the day when the participants return to work and normal activities
- Participants' satisfaction post-procedure [ Time Frame: 3 days post-op ]To rate satisfaction with overall teatment regime with a numerical scale of 0 (least satisfied) to 10 (most satisfied) through an app named Recovery+
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| Ages Eligible for Study: | 18 Years to 90 Years (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04645771
| Contact: Chunshui He, Doctor | 18981885601 | chunshuihe@msn.com |
| China, Sichuan | |
| Hospital of Chengdu University of Traditional Chinese Medicine | Recruiting |
| Chengdu, Sichuan, China, 610000 | |
| Contact: Ye Gao, Master 18883367703 18883367703@163.com | |
| Responsible Party: | Chunshui He, Director of Vascular Surgery in ChengduUTCM, Chengdu University of Traditional Chinese Medicine |
| ClinicalTrials.gov Identifier: | NCT04645771 |
| Other Study ID Numbers: |
ChengduUTCMvs |
| First Posted: | November 27, 2020 Key Record Dates |
| Last Update Posted: | May 16, 2022 |
| Last Verified: | May 2022 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | No |
| Studies a U.S. FDA-regulated Drug Product: | No |
| Studies a U.S. FDA-regulated Device Product: | No |
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microwave ablation varicose veins traditional treatment |
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Vascular Diseases Venous Insufficiency Varicose Veins Peripheral Vascular Diseases Peripheral Arterial Disease |
Cardiovascular Diseases Atherosclerosis Arteriosclerosis Arterial Occlusive Diseases |