Clinical trial NCT04339075: Registry to Investigate the Efficacy and Safety of VenaBlock VeIn SEaling System for VaRicose Veins in SingApore
Official title: Registry to Investigate the Efficacy and Safety of VenaBlock VeIn SEaling System for VaRicose Veins in SingApore
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: 30
Sex: ALL
Minimum age (years): 21
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients who will be undergoing Venablock© as a treatment for their varicose veins / chronic venous insufficiency

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

1. Age \> 21 years old and ability to understand the requirements of the study and to provide informed consent
2. C2-C6 varicose veins/CVI (CEAP Class 1 patients will be excluded)
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 had GSV, SSV or AASV diameters of 3mm to 12mm in the standing position

Exclusion Criteria:

1. Current DVT or history of DVT
2. Pregnant patients
3. Arterial disease (ABPI\<0.8)
4. Sepsis
5. Patient who are unwilling to participate
6. Inability or unwillingness to complete the time-point questionnaires
7. Adverse reaction to sclerosant or cyanoacrylate previously
8. Multiple drug allergies
9. Previous intervention with the VenaSeal cyanoacrylate glue closure system
10. Severely tortuous GSV, SSV or AASV
11. Life expectancy \< 1 year
12. Active treatment for malignancy other than non-melanoma skin cancer
13. Current, regular use of systemic anticoagulation (e.g., warfarin, heparin)
14. Daily use of narcotic analgesia or NSAIDS to control pain associated with venous disease

Primary outcomes:
measure: Occlusion of treated vein post-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 the 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: Recorded 10 days post-procedure
measure: Occlusion rates
timeFrame: 2 weeks, 3 months, 6 months, 12 months post-procedure
measure: Patient satisfaction with treatment: survey
timeFrame: 2 weeks, 3 months, 6 months, 12 months post-procedure
measure: Cost effectiveness of the intervention
timeFrame: 12 months post-procedure
Other outcomes:
Locations:
city: Singapore
country: Singapore
facility: Singapre General Hospital
Study officials:
affiliation: Singapore General Hospital
name: Turn Yip Tang
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.