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To assess the efficacy of the Venablock©Vein Sealing System (VBVS) for the treatment of lower extremity superficial truncal veins in a real-world clinical setting in a multi-racial Asian population in Singapore.
The purpose of the Registry to Investigate the Efficacy and Safety of Venablock©Vein Sealing System for Varicose Veins in Singapore (RIVERIA), is to investigate the performance of cyanoacrylate glue closure (CAC) using this device, in which multiple incompetent superficial saphenous truncal veins (great saphenous (GSV), short saphenous vein (SSV), anterior accessory saphenous vein (AASV) will be treated at the same setting, and compression stockings will not be used post-operatively. The inclusion criteria for this study will be liberalized, and veins up to 12mm in diameter will be treated. As such,RIVIERA will be the first prospective trial conducted in Asia on a predominantly Asian cohort of patients to report on the performance of Venablock© for blocking incompetent truncal veins. This study specifically focuses on the initial technical outcomes, safety, anatomical occlusion, and patient experience after treatment with Venablock© with broader inclusion of patients than previous caucasian based trials.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Venablock | Patients that have undergone Venablock treatment |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Questionnaires | Other | Questionnaires to access the quality of life (EQ5D, VCSS, CVVQ, CIVIQ, Patient satisfaction survey) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Occlusion of treated vein post-procedure | Immediately post-op | |
| Change in anatomy of treated vessel | Anatomical Success as measured at each timepoint using ultrasound to ensure occlusion of treated vessel. Recurrence or treatment failure will be defined as a re-opening of a segment > 5cm in length. | 2 weeks, 3 months, 6 months, 12 months post-procedure |
| Measure | Description | Time Frame |
|---|---|---|
| Quality of Life Score using the 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. The higher the score, the better the quality of life is. |
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Inclusion Criteria:
Exclusion Criteria:
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Patients who will be undergoing Venablock© as a treatment for their varicose veins / chronic venous insufficiency
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| Name | Affiliation | Role |
|---|---|---|
| Turn 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 |
|---|---|---|---|
| 25075589 | Background | Nesbitt C, Bedenis R, Bhattacharya V, Stansby G. Endovenous ablation (radiofrequency and laser) and foam sclerotherapy versus open surgery for great saphenous vein varices. Cochrane Database Syst Rev. 2014 Jul 30;(7):CD005624. doi: 10.1002/14651858.CD005624.pub3. | |
| 22705163 | Background | Siribumrungwong B, Noorit P, Wilasrusmee C, Attia J, Thakkinstian A. A systematic review and meta-analysis of randomised controlled trials comparing endovenous ablation and surgical intervention in patients with varicose vein. Eur J Vasc Endovasc Surg. 2012 Aug;44(2):214-23. doi: 10.1016/j.ejvs.2012.05.017. Epub 2012 Jun 15. |
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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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| 2 weeks, 3 months, 6 months, 12 months post-procedure |
| 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 | Recorded 10 days post-procedure |
| 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: survey | A short survey to assess patient satisfaction and if there are any observed improvement in terms of appearance and symptoms post-procedure. Options range from highly unsatisfied to highly satisfied. | 2 weeks, 3 months, 6 months, 12 months post-procedure |
| Cost effectiveness of the intervention | to evaluate the cost involved with the procedure performed | 12 months post-procedure |
| 18278775 | Background | Darwood RJ, Theivacumar N, Dellagrammaticas D, Mavor AI, Gough MJ. Randomized clinical trial comparing endovenous laser ablation with surgery for the treatment of primary great saphenous varicose veins. Br J Surg. 2008 Mar;95(3):294-301. doi: 10.1002/bjs.6101. |
| 21725957 | Background | Rasmussen LH, Lawaetz M, Bjoern L, Vennits B, Blemings A, Eklof B. Randomized clinical trial comparing endovenous laser ablation, radiofrequency ablation, foam sclerotherapy and surgical stripping for great saphenous varicose veins. Br J Surg. 2011 Aug;98(8):1079-87. doi: 10.1002/bjs.7555. |
| 23884969 | Background | Marsden G, Perry M, Kelley K, Davies AH; Guideline Development Group. Diagnosis and management of varicose veins in the legs: summary of NICE guidance. BMJ. 2013 Jul 24;347:f4279. doi: 10.1136/bmj.f4279. No abstract available. |
| 20473992 | Background | Shepherd AC, Gohel MS, Brown LC, Metcalfe MJ, Hamish M, Davies AH. Randomized clinical trial of VNUS ClosureFAST radiofrequency ablation versus laser for varicose veins. Br J Surg. 2010 Jun;97(6):810-8. doi: 10.1002/bjs.7091. |
| 20150227 | Background | Shepherd AC, Gohel MS, Lim CS, Hamish M, Davies AH. Pain following 980-nm endovenous laser ablation and segmental radiofrequency ablation for varicose veins: a prospective observational study. Vasc Endovascular Surg. 2010 Apr;44(3):212-6. doi: 10.1177/1538574409359337. Epub 2010 Feb 11. |
| 17988905 | Background | Rabe E, Otto J, Schliephake D, Pannier F. Efficacy and safety of great saphenous vein sclerotherapy using standardised polidocanol foam (ESAF): a randomised controlled multicentre clinical trial. Eur J Vasc Endovasc Surg. 2008 Feb;35(2):238-45. doi: 10.1016/j.ejvs.2007.09.006. Epub 2007 Nov 7. |
| 25650040 | Background | Morrison N, Gibson K, McEnroe S, Goldman M, King T, Weiss R, Cher D, Jones A. Randomized trial comparing cyanoacrylate embolization and radiofrequency ablation for incompetent great saphenous veins (VeClose). J Vasc Surg. 2015 Apr;61(4):985-94. doi: 10.1016/j.jvs.2014.11.071. Epub 2015 Jan 31. |
| 26908638 | Background | Tang TY, Kam JW, Gaunt ME. ClariVein(R) - Early results from a large single-centre series of mechanochemical endovenous ablation for varicose veins. Phlebology. 2017 Feb;32(1):6-12. doi: 10.1177/0268355516630154. Epub 2016 Jul 9. |
| 21638147 | Background | Vanlangenhove P, De Keukeleire K, Everaert K, Van Maele G, Defreyne L. Efficacy and safety of two different n-butyl-2-cyanoacrylates for the embolization of varicoceles: a prospective, randomized, blinded study. Cardiovasc Intervent Radiol. 2012 Jun;35(3):598-606. doi: 10.1007/s00270-011-0188-9. Epub 2011 Jun 3. |
| 2505505 | Background | Brothers MF, Kaufmann JC, Fox AJ, Deveikis JP. n-Butyl 2-cyanoacrylate--substitute for IBCA in interventional neuroradiology: histopathologic and polymerization time studies. AJNR Am J Neuroradiol. 1989 Jul-Aug;10(4):777-86. |
| 30655108 | Background | Ovali C, Sevin MB. Twelve-month efficacy and complications of cyanoacrylate embolization compared with radiofrequency ablation for incompetent great saphenous veins. J Vasc Surg Venous Lymphat Disord. 2019 Mar;7(2):210-216. doi: 10.1016/j.jvsv.2018.10.019. Epub 2019 Jan 14. |
| 29642798 | Background | Yavuz T, Acar AN, Aydin H, Ekingen E. A retrospective study of a new n-butyl-2-cyanoacrylate glue ablation catheter incorporated with application guiding light for the treatment of venous insufficiency: Twelve-month results. Vascular. 2018 Oct;26(5):547-555. doi: 10.1177/1708538118770548. Epub 2018 Apr 11. |
| 31032714 | Background | Lee Q, Gibson K, Chan SL, Rathnaweera HP, Chong TT, Tang TY. A comparison between Caucasian and Asian superficial venous anatomy and reflux patterns - Implications for potential precision endovenous ablation therapy. Phlebology. 2020 Feb;35(1):39-45. doi: 10.1177/0268355519845984. Epub 2019 Apr 29. No abstract available. |
| D011787 | Quality of Health Care |
| D017530 | Health Care Quality, Access, and Evaluation |
| D011634 | Public Health |
| D004778 | Environment and Public Health |