High Intensity Focused Ultrasound in PAtients With Varicose Veins in Singapore

Varicose Veins Clinical Trial

— VESPA  

Official title:

Pilot Study to InVestigate the Efficacy and Safety of High Intensity Focused Ultrasound in PAtients With Varicose Veins in Singapore (VESPA)

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04339088
• Other study ID #: 2019/2933
• Status: Not yet recruiting
• Start date: March 1, 2022
• Est. completion date: December 1, 2023

Study information

• Verified date: September 2021
• Source: Singapore General Hospital
• Contact: Charyl Yap
• Phone: 65767986
• Email: charyl.yap.j.q[@]sgh.com.sg
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 15
• Est. completion date: December 1, 2023
• Est. primary completion date: December 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• Chronic Venous Insufficiency
• Varicose Veins
• Venous Insufficiency
• Venous Reflux

Intervention

Other:
• Questionnaires
Questionnaires to assess quality of life

Locations

Country	Name	City	State
Singapore	Singapre General Hospital	Singapore

Sponsors (1)

Lead Sponsor	Collaborator
Singapore General Hospital

Country where clinical trial is conducted

Singapore, 

References & Publications (8)

Callam MJ. Epidemiology of varicose veins. Br J Surg. 1994 Feb;81(2):167-73. Review. — View Citation

Golledge J, Quigley FG. Pathogenesis of varicose veins. Eur J Vasc Endovasc Surg. 2003 Apr;25(4):319-24. Review. — View Citation

Jawien A. The influence of environmental factors in chronic venous insufficiency. Angiology. 2003 Jul-Aug;54 Suppl 1:S19-31. Review. — View Citation

Law, Y., Chan, Y. C., Cheung, G. C. Y., Ting, A. C. W., Wong, A. C. C., & Cheng, S. W. K. (2016). Early single-centre comparative results on non-thermal ablation of symptomatic incompetent great saphenous veins (GSV): cyanoacrylate glue (VenaSeal) versus mechanicochemical ablation (ClariVein). Leipzig Interventional Course, LINC 2016.

Navarro L, Min RJ, Boné C. Endovenous laser: a new minimally invasive method of treatment for varicose veins--preliminary observations using an 810 nm diode laser. Dermatol Surg. 2001 Feb;27(2):117-22. — View Citation

Subramonia S, Lees T. Radiofrequency ablation vs conventional surgery for varicose veins - a comparison of treatment costs in a randomised trial. Eur J Vasc Endovasc Surg. 2010 Jan;39(1):104-11. doi: 10.1016/j.ejvs.2009.09.012. Epub 2009 Oct 29. — View Citation

Tan KK, Nalachandran S, Chia KH. Endovenous laser treatment for varicose veins in Singapore: a single centre experience of 169 patients over two years. Singapore Med J. 2009 Jun;50(6):591-4. — View Citation

Teruya TH, Ballard JL. New approaches for the treatment of varicose veins. Surg Clin North Am. 2004 Oct;84(5):1397-417, viii-ix. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Technical success at time of procedure	Occlusion of treated vein post-procedure	Immediately post-op
Primary	Change in anatomy of treated vessel	Anatomical success as measured at each time-point using ultrasound to ensure occlusion of treated vein.	2 weeks, 3 months, 6 months, 12 months post-procedure
Secondary	Quality of life score using EQ-5D questionnaire	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.	2 weeks, 3 months, 6 months, 12 months post-procedure
Secondary	Quality of Life Score using the Chronic Venous Insufficiency Questionnaire (CIVIQ)	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.	2 weeks, 3 months, 6 months, 12 months post-procedure
Secondary	Quality of Life score using the Aberdeen Varicose Vein Questionnaire (AVVQ)	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	2 weeks, 3 months, 6 months, 12 months post-procedure
Secondary	Clinical Change using Venous Clinical Severity Score (VCSS)	VCSS evaluates the severity of hallmarks of venous disease - 0 (none), 1 (mild), 2 (moderate), 3 (severe).	2 weeks, 3 months, 6 months, 12 months post-procedure
Secondary	Pain Score	Using a numerical rating scale, which ranges from 0 (no pain) to 10 (severe pain)	First 10 days post-procedure
Secondary	Time taken to return to work and normal activities		10 days post-operation
Secondary	Occlusion rates	Duplex ultrasound performed at specific timepoints to ensure that treated vein is occluded	2 weeks, 3 months, 6 months, 12 months post-procedure
Secondary	Patient satisfaction with treatment	A short survey to assess patient satisfaction and if there is any observed improvement in terms of appearance and symptoms post-procedure.	2 weeks, 3 months, 6 months, 12 months post-procedure