A Singapore Venaseal Real World Post-Market Evaluation Study
NCT ID: NCT03893201
Last Updated: 2020-03-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
100 participants
OBSERVATIONAL
2018-04-11
2020-01-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Venaseal
Patients that have undergone venaseal
Questionnaires
Questionnaires to assess quality of life
Interventions
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Questionnaires
Questionnaires to assess quality of life
Eligibility Criteria
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Inclusion Criteria
* C2 - C5 symptomatic veins / Chronic Venous Insufficiency
* 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
* Patients who had GSV, SSV or AASV diameters of 3mm to 12mm in the standing position
Exclusion Criteria
* Recurrent varicose veins
* Pregnant patients
* Arterial Disease (ABPI\<0.8)
* Sepsis
* Patients who are unwilling to participate
* Inability or unwillingness to complete questionnaires
* Adverse reaction to sclerosant or cyanoacrylate
* GSV, SSV or AASV severely tortuous
* Life expectancy \< 1 year
* Active treatment for malignancy other than non-melanoma skin cancer
* Current, regular use of systemic anticoagulation (e.g. warfarin, heparin)
* Daily use of narcotic analgesia or NSAIDS to control pain associated with venous disease
21 Years
90 Years
ALL
No
Sponsors
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Singapore General Hospital
OTHER
Responsible Party
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Principal Investigators
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Tjun Yip Tang
Role: PRINCIPAL_INVESTIGATOR
Singapore General Hospital
Locations
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Singapore General Hospital
Singapore, , Singapore
Sengkang General Hospital
Singapore, , Singapore
Countries
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References
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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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Tang TY, Yap CJQ, Chan SL, Soon SXY, Khoo VBX, Choke E, Chong TT. 3-year clinical outcomes of A Singapore VenaSeal real world post-market evaluation Study (ASVS) for varicose vein ablation. CVIR Endovasc. 2024 Apr 27;7(1):41. doi: 10.1186/s42155-024-00452-8.
Tang TY, Yap CJQ, Chan SL, Soon SXY, Yap HY, Lee SQW, Choke ETC, Chong TT. Early results of an Asian prospective multicenter VenaSeal real-world postmarket evaluation to investigate the efficacy and safety of cyanoacrylate endovenous ablation for varicose veins. J Vasc Surg Venous Lymphat Disord. 2021 Mar;9(2):335-345.e2. doi: 10.1016/j.jvsv.2020.03.020. Epub 2020 May 7.
Other Identifiers
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2017/2087
Identifier Type: -
Identifier Source: org_study_id
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