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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| HIFU | Patients that have undergone high focused ultrasound treatment for varicose veins |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Questionnaires | Other | Questionnaires to assess quality of life |
|
| Measure | Description | Time Frame |
|---|---|---|
| Technical success at time of procedure | Occlusion of treated vein post-procedure | Immediately post-op |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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The study involves prospective data collection of 30 patients that will be undergoing HIFU as a choice of treatment for their varicose veins / CVI.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Charyl Yap | Contact | 65767986 | charyl.yap.j.q@sgh.com.sg |
| Name | Affiliation | Role |
|---|---|---|
| Tjun Yip Tang | Singapore General Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Singapre General Hospital | Singapore | 169608 | Singapore |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 12651169 | Background | 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. | |
| 8156326 | Background | Callam MJ. Epidemiology of varicose veins. Br J Surg. 1994 Feb;81(2):167-73. doi: 10.1002/bjs.1800810204. |
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| ID | Term |
|---|---|
| D014648 | Varicose Veins |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| D011795 | Surveys and Questionnaires |
| ID | Term |
|---|---|
| D003625 | Data Collection |
| D004812 | Epidemiologic Methods |
| D008919 | Investigative Techniques |
| D017531 | Health Care Evaluation Mechanisms |
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| 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 |
| 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 |
| 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 |
| Pain Score | Using a numerical rating scale, which ranges from 0 (no pain) to 10 (severe pain) | First 10 days post-procedure |
| Time taken to return to work and normal activities | 10 days post-operation |
| 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 |
| 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 |
| 19551312 | Background | 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. |
| 12934754 | Background | Jawien A. The influence of environmental factors in chronic venous insufficiency. Angiology. 2003 Jul-Aug;54 Suppl 1:S19-31. doi: 10.1177/0003319703054001S04. |
| 11207682 | Background | 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. |
| Background | 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. |
| 15364562 | Background | 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. |
| 19879166 | Background | 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. |
| D011787 | Quality of Health Care |
| D017530 | Health Care Quality, Access, and Evaluation |
| D011634 | Public Health |
| D004778 | Environment and Public Health |