High Intensity Focused Ultrasound in PAtients With Varicose Veins in Singapore

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

• Registration Number: NCT04339088
• Lead Sponsor: Singapore General Hospital

Brief Summary

The aim of the study is to evaluate the efficacy of non-invasive echotherapy for the treatment of varicose veins, within local population, using the Sonovein® device. The quality of life scores at baseline, 2 weeks, 3 months, 6 months and 12 months will be assessed using the EQ-50D, AVVQ and CIVIQ scores. Patient satisfaction at these time points will also be assessed.

Detailed Description

Sonovein® is a unique echotherapy solution, combining therapeutic ultrasound and ultrasound for monitoring. The high-intensity ultrasound beam is focused on the vein through a magnifying glass. As thermal energy is delivered, the thermocoagulation property of ultrasound energy affects the vein wall, causing shrinking and collapsing of the target vein. Thus creating a fibrotic seal and occluding the vessel. The treated vein is immediately closed after the procedure, and its diameter will continuously reduce over time, becoming a fibrotic chord. The treatment along the vein is steered automatically via a touch screen monitor. In-beam linear ultrasound probe allows visualisation of the vein in real-time and insures optimal accuracy. The study involves prospective data collection of 30 patients that will be undergoing HIFU as choice of treatment for their varicose veins / CVI. Questionnaires will be conducted at 5 timepoints - baseline before procedure, 2 weeks, 3 months, 6 months and 12 months. Subjects will be seen at outpatient clinic post-procedure. Besides questionnaires, physical examination and duplex ultrasound scan will be conducted at 2 weeks, 3 months, 6 months and 12 months to ensure occlusion of treated vein.

Study Timeline

• Study First Submitted: 2020-04-06
• Study First Submitted QC: 2020-04-06
• Study First Posted: 2020-04-09
• Status Verified: 2021-09
• Last Update Submitted: 2021-09-23
• Last Update Posted: 2021-09-27
• Study Start: 2022-03-01
• Primary Completion: 2022-12-01
• Study Completion: 2023-12-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 15

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 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.
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
HIFU	Questionnaires	Patients that have undergone high focused ultrasound treatment for varicose veins

Primary Outcome Measures

Name	Time	Method
Change in anatomy of treated vessel	2 weeks, 3 months, 6 months, 12 months post-procedure	Anatomical success as measured at each time-point using ultrasound to ensure occlusion of treated vein.
Technical success at time of procedure	Immediately post-op	Occlusion of treated vein post-procedure

Secondary Outcome Measures

Name	Time	Method
Time taken to return to work and normal activities	10 days post-operation
Quality of life score using 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.
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
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).
Pain Score	First 10 days post-procedure	Using a numerical rating scale, which ranges from 0 (no pain) to 10 (severe pain)
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.
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
Patient satisfaction with treatment	2 weeks, 3 months, 6 months, 12 months post-procedure	A short survey to assess patient satisfaction and if there is any observed improvement in terms of appearance and symptoms post-procedure.

Trial Locations

Locations (1)

Singapre General Hospital; 🇸🇬 Singapore, Singapore