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

November 7, 2022 updated by: Chunshui He, Chengdu University of Traditional Chinese Medicine
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.

Study Overview

Status

Recruiting

Conditions

Intervention / 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.

Study Type

Interventional

Enrollment (Anticipated)

50

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Sichuan
      • Chengdu, Sichuan, China, 610000
        • Recruiting
        • Hospital of Chengdu University of Traditional Chinese Medicine
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.
Procedure: Questionnaires
Questionnaires to assess the quality of life (EQ-5D, CVVQ, CIVIQ, AVVQ, Patient satisfaction survey)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Immediately 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
3days
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
12 months post-procedure

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Immediately post-procedure
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
Baseline, 1 month, 6 months and 12 months
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.
Baseline, 1 month, 6 months and 12 months
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.
Baseline, 1 month, 6 months and 12 months
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.
Baseline, 1 month, 6 months and 12 months
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
10 days post-op
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+
3 days post-op

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Chengdu University of Traditional Chinese Medicine

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 4, 2021

Primary Completion (Anticipated)

November 1, 2022

Study Completion (Anticipated)

December 5, 2022

Study Registration Dates

First Submitted

October 31, 2020

First Submitted That Met QC Criteria

November 22, 2020

First Posted (Actual)

November 27, 2020

Study Record Updates

Last Update Posted (Actual)

November 8, 2022

Last Update Submitted That Met QC Criteria

November 7, 2022

Last Verified

November 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ChengduUTCMvs

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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