Efficacy and Safety of Endovenous Microwave Ablations for Treatment of Varicose Veins in Singapore

NCT ID: NCT04524793

Last Updated: 2021-09-27

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-05-09
• Study Completion Date: 2021-12-31

Brief Summary

The purpose of this study is to assess change in patient's symptoms before and after Endovenous Microwave Ablation (EMA) as treatment for varicose veins. At the same time, it is to evaluate the effectiveness of EMA and its treatment outcomes over a period of 1 year.

Detailed Description

Healthy leg veins have valves that allow blood to move in one direction from the lower leg to the heart. These valves open when blood is flowing toward the heart and then quickly close to stop any backward flow. When veins weaken, their valves cannot close properly, causing reversal of blood flow in the vein or venous reflux. Venous reflux due to the incompetent valves in the superficial venous system is the most common form of venous insufficiency, also known as varicose veins. This happens most often in the veins closest to the skin; the superficial veins. Varicose veins may or may not have associated symptoms and can look like twisted, bulging, rope-like cords or even small spider veins. While sometimes asymptomatic, varicose veins can be associated with pain, aching or cramping in the legs, heaviness or a tired sensation, paresthesia, pruritus, edema, inflammation with superficial phlebitis or thrombophlebitis, ulceration, bleeding from ulcerated varicosities, ecchymosis from subcutaneous rupture of varicosities, and deep venous thrombosis from extension of superficial thrombophlebitis.

Venous insufficiency of lower extremities is a very common condition that is influenced by genetic and mechanical factors, and is a chronic and progressive disorder. Prevalence estimates vary widely by geographic location, with the highest reported rates in Western countries, including Western Europe and the United States. Prevalence estimates of varicose veins range from <1% to up to 73% in females and 2% to up to 56% in males. The reported prevalence ranges presumably reflect differences in the population distribution of risk factors, accuracy in application of diagnostic criteria, and the quality and availability of medical diagnostic and treatment resources. Risk factors for venous insufficiency include older age, female gender and pregnancy, family history of venous disease, obesity and occupations associated with prolonged standing.

There are a number of treatment options available to subjects with varicose veins, including vein stripping surgery, and thermal ablation; for example, Endovenous laser ablation (EVLA), radiofrequency ablation (RFA), and sclerotherapy. Recent technological advances have also brought about new treatment methods that are non-thermal, non-tumescent (NTNT). These include Venaseal and Clarivein. The goal of each of these treatment regimens is to eliminate source of reflux in order to control the progression of the disease, improve symptoms, promote ulcer healing, and prevent recurrence or a combination of these. The latest treatment available uses microwave ablation, which is a sub-type of radiofrequency and has the same characteristics as radiofrequency ablation.

The aim of this study is to report a collaborative, prospective Singaporean 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 performance.

Conditions

Venous Insufficiency; Varicose Veins; Vascular Diseases

Study Design

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

Study Groups

Endovenous Microwave Ablations

Patients that have undergone Endovenous Microwave Ablation from ECO (Nanjing ECO Microwave System Co., Ltd) to treat primary great and short saphenous vein reflux

Group Type: OTHER

Questionnaires

Intervention Type: OTHER

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

Physical examinations

Intervention Type: OTHER

GSV/SSV/AASV reflux, CEAP Classification (Clinical, Aetiological, Anatomical and Pathophysiology), Venous Clinical Severity Score (VCSS) and duplex ultrasound

Interventions

Questionnaires

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

Intervention Type: OTHER

Physical examinations

GSV/SSV/AASV reflux, CEAP Classification (Clinical, Aetiological, Anatomical and Pathophysiology), Venous Clinical Severity Score (VCSS) and duplex ultrasound

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Age >21 years, able to understand the requirements of the study and provide informed consent.
• 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.

Exclusion Criteria

• Current DVT or history of DVT
• Recurrent varicose veins
• Pregnant patients
• Arterial disease (ABPI <0.8)
• Sepsis
• Patients who are unwilling to participate
• Inability or unwillingness to complete questionnaires
• Adverse reaction to sclerosant or cyanoacrylate
• GSV, SSV or AASV severely tortuous
• Life expectancy < 1 year
• Active treatment for malignancy other than non-melanoma skin cancer
• Current, regular use of systemic anticoagulation (e.g. warfarin, heparin)
• Daily us of narcotic analgesia or NSAIDS to control pain associated with venous disease

• Minimum Eligible Age: 21 Years
• Maximum Eligible Age: 99 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Singapore General Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Tang Tjun Yip

Role: PRINCIPAL_INVESTIGATOR

Singapore General Hospital

Locations

Singapore General Hospital

Singapore, , Singapore

Countries

Singapore

References

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Reference Type: BACKGROUND

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Reference Type: BACKGROUND

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Reference Type: BACKGROUND

PMID: 26163507 (View on PubMed)

Other Identifiers

2020/2371

Identifier Type: -

Identifier Source: org_study_id