Clinical trial NCT04339088: High Intensity Focused Ultrasound in PAtients With Varicose Veins in Singapore
Official title: Pilot Study to InVestigate the Efficacy and Safety of High Intensity Focused Ultrasound in PAtients With Varicose Veins in Singapore (VESPA)
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Varicose Veins
Venous Reflux
Chronic Venous Insufficiency
Keywords: Endovenous Ablation
Lead sponsor: Singapore General Hospital
Sponsor class: OTHER
First posted: 2020-04-09
Enrollment: 15
Sex: ALL
Minimum age (years): 21
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study involves prospective data collection of 30 patients that will be undergoing HIFU as a choice of treatment for their varicose veins / CVI.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Technical success at time of procedure
timeFrame: Immediately post-op
measure: Change in anatomy of treated vessel
timeFrame: 2 weeks, 3 months, 6 months, 12 months post-procedure
Secondary outcomes:
measure: Quality of life score using EQ-5D questionnaire
timeFrame: 2 weeks, 3 months, 6 months, 12 months post-procedure
measure: Quality of Life Score using the Chronic Venous Insufficiency Questionnaire (CIVIQ)
timeFrame: 2 weeks, 3 months, 6 months, 12 months post-procedure
measure: Quality of Life score using the Aberdeen Varicose Vein Questionnaire (AVVQ)
timeFrame: 2 weeks, 3 months, 6 months, 12 months post-procedure
measure: Clinical Change using Venous Clinical Severity Score (VCSS)
timeFrame: 2 weeks, 3 months, 6 months, 12 months post-procedure
measure: Pain Score
timeFrame: First 10 days post-procedure
measure: Time taken to return to work and normal activities
timeFrame: 10 days post-operation
measure: Occlusion rates
timeFrame: 2 weeks, 3 months, 6 months, 12 months post-procedure
measure: Patient satisfaction with treatment
timeFrame: 2 weeks, 3 months, 6 months, 12 months post-procedure
Other outcomes:
Locations:
city: Singapore
country: Singapore
facility: Singapre General Hospital
Study officials:
affiliation: Singapore General Hospital
name: Tjun Yip Tang
role: PRINCIPAL_INVESTIGATOR
References:
citation: Golledge J, Quigley FG. Pathogenesis of varicose veins. Eur J Vasc Endovasc Surg. 2003 Apr;25(4):319-24. doi: 10.1053/ejvs.2002.1843.
citation: Callam MJ. Epidemiology of varicose veins. Br J Surg. 1994 Feb;81(2):167-73. doi: 10.1002/bjs.1800810204.
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.
citation: Jawien A. The influence of environmental factors in chronic venous insufficiency. Angiology. 2003 Jul-Aug;54 Suppl 1:S19-31. doi: 10.1177/0003319703054001S04.
citation: Navarro L, Min RJ, Bone 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. doi: 10.1046/j.1524-4725.2001.00134.x.
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.
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. doi: 10.1016/j.suc.2004.04.008.
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.