Efficacy and Safety of Endovenous Radio Frequency (EVRF) for Treatment of Varicose Veins in Singapore

• Conditions: Varicose Veins; Venous Reflux; Chronic Venous Insufficiency
• Interventions: Other: Questionnaires

• Registration Number: NCT04384315
• Lead Sponsor: Singapore General Hospital

Brief Summary

The aim of this study is to report a collaborative, prospective Singaporean experience using the Endovenous Radio Frequency® (EVRF®) from F Care Systems (Belgian) for the treatment of primary great and short saphenous vein reflux.

Detailed Description

The investigators wish to evaluate its safety, efficacy, and performance. Although it has been shown to be safe and efficacious in its initial trials, these studies have been limited to generally a caucasian-based population, where the vein size, anatomy and distribution of venous incompetence can be different from their asian counterparts. The study will evaluate the technical, anatomical and clinical performance of EVRF® performed on multiple truncal varicose veins, and without mandatory postoperative compression stockings of the GSV, SSV or AASV. The two primary endpoints for this evaluation are technical success at the time of the procedure, and anatomical success, reported as complete closure at 2-weeks, 3 months, 6 months and 12 months.

Study Timeline

• Study Start: 2019-08-01
• Study First Submitted: 2020-04-06
• Study First Submitted QC: 2020-05-10
• Study First Posted: 2020-05-12
• Status Verified: 2021-09
• Last Update Submitted: 2021-09-23
• Last Update Posted: 2021-09-27
• Primary Completion: 2021-12-01
• Study Completion: 2022-12-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

1. Age >21 years, able to understand the requirements of the study and provide informed consent.
2. C2 - C5 varicose veins / CVI
3. Symptomatic primaryGSV, 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.
4. Patients who has GSV, SSV or AASV diameters of 3mm to 12mm in the standing position.

Exclusion Criteria

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
EVRF	Questionnaires	Patients that have undergone Endovenous Radio Frequency® (EVRF®) from F Care Systems (Belgian) for the treatment of primary great and short saphenous vein reflux.

Primary Outcome Measures

Name	Time	Method
Technical Success at time of procedure	Immediately post-procedure	Occlusion of treated vein post-procedure
Anatomical Success	2 weeks to 12 months post-procedure	Anatomical success defined as occlusion of treated vessel, as determined by duplex ultrasound.

Secondary Outcome Measures

Name	Time	Method
Time taken to return to work and normal activities	10 days post-operation
Clinical Change using Venous Clinical Severity Score (VCSS)	2 weeks, 3 months, 6 months, 12 months post-procedure	VCSS evaluates the severity of hallmarks of venous disease - 0 (none), 1 (mild), 2 (moderate), 3 (severe).
Patient satisfaction with treatment: survey	2 weeks, 3 months, 6 months, 12 months post-procedure	A short survey to assess patient satisfaction and if there are any observed improvement in terms of appearance and symptoms post-procedure.
Quality of Life Score using the Chronic Venous Insufficiency Questionnaire (CIVIQ)	2 weeks, 3 months, 6 months, 12 months post-procedure	CIVIQ 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, Global Index Score (GIS) will be tabulated, ranging for 0 to 100 - the higher the value, the poorer the quality of life.
Quality of Life score using the Aberdeen Varicose Vein Questionnaire (AVVQ)	2 weeks, 3 months, 6 months, 12 months post-procedure	To measure health status of varicose veins patients based on symptoms and impact on daily activities. A total score ranging from 0 to 100 will be tabulated, with 100 being worst quality of life
Occlusion rates	2 weeks, 3 months, 6 months, 12 months post-procedure	Duplex ultrasound performed at specific timepoints to ensure that treated vein is occluded
Pain Score	First 10 days post-operation	Using a numerical rating scale, which ranges from 0 (no pain) to 10 (severe pain)
Quality of Life Score using the EQ-5D questionnaire	2 weeks, 3 months, 6 months, 12 months post-procedure	EQ5D 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 for changes in quality of life overtime.

Trial Locations

Locations (1)

Singapre General Hospital; 🇸🇬 Singapore, Singaopore, Singapore